BRAIN CANCER STUDIES:
Study: NCCTG N0779
“Phase II Study of Vorinostat (SAHA) in Combination with Bortezomib (PS-341) in Patients with Recurrent Glioblastoma Multiforme ”
Purpose:
• find out what effects (good and bad) vorinostat and bortezomib in combination have on you and your brain tumor
• look at vorinostat and bortezomib’s ability to slow down the growth of your tumor
Vorinostat is a U.S. Food and Drug Administration (FDA) approved drug indicated for the treatment of cutaneous T-cell lymphoma, a cancer of blood cells that infiltrates the skin. Bortezomib is an FDA-approved drug used in the treatment of multiple myeloma, a cancer of one of the bone marrow cells. The combination of vorinostat and bortezomib in this setting is investigational, which means they have not been approved for this use by the FDA.
BREAST CANCER STUDIES:
Study: AC01B07
"A Double-Blind, Randomized Phase 2b Study of Sorafenib Compared to Placebo when Administered in Combination with Chemotherapy for Patients with Locally Advanced or Metastatic Breast Cancer that has Progressed During or After Bevacizumab Therapy"
Purpose: The purpose of this study is to compare the effects of gemcitabine, a commonly used chemotherapy drug, when given either with sorafenib or placebo (a sugar pill / inactive substance) on patients with metastatic breast cancer that have progressed during or after standard treatment with bevacizumab. Sorafenib is a new type of anti-cancer drug. Placebo does not contain active medication and should not influence the effect of gemcitabine. Sorafenib may influence the effect, good and/or bad, of gemcitabine. Determining what effect sorafenib might have is the purpose of this study. Participants will get either sorafenib with gemcitabine or placebo with gemcitabine. They will not get both regimens.
Sorafenib is approved for treatment for other cancers, but has not been approved by the U.S. Food and Drug Administration (FDA) for use in breast cancer.
Gemcitabine is FDA approved for use in patients with breast cancer that has spread to other parts of their body or has relapsed (returned). The use of sorafenib along with gemcitabine in this research is experimental.
Study: CTSU E1105
"A Randomized Phase III Double-Blind Placebo Controlled Trial of First-Line Chemotherapy and Trastuzumab with or without Bevacizumab for Patients with HER-2/NEU Over-expressing Metastatic Breast Cancer."
Purpose: This research is being done in order to develop more effective treatments for patients with breast cancer that has spread (metastatic) and that has high levels of a protein called HER-2/NEU in their tumor. The standard treatment, chemotherapy plus trastuzumab (HerceptinTM) has been shown to help control the type of metastatic breast cancer that expresses a protein called HER-2/NEU. However, in many cases the tumor eventually grows back. The purpose of this study is to see if adding the drug bevacizumab to the currently accepted therapy of trastuzumab and chemotherapy causes a delay in the progression of the tumor compared to trastuzumab and chemotherapy alone.
In this study, participants will be randomized to get either bevacizumab in combination with trastuzumab and chemotherapy, or a placebo for bevacizumab (an infusion in the vein that has no active medicine in it) with trastuzumab and chemotherapy, which is the current treatment for this type of cancer. Trastuzumab is a type of anticancer drug that is commercially available, and that has been shown to be effective in breast cancers that are positive for the protein HER-2/NEU. Bevacizumab is an investigational drug and has not yet been approved by the FDA for the treatment of breast cancer.
Bevacizumab is the common name for the commercial drug Avastin. However, the bevacizumab used in this study is an investigational drug and has not yet been approved by the FDA for treatment in breast cancer. The bevacizumab that is being used in this study is for use in research studies only and may be made at locations different from those where Avastin is made.
Study: CTSU E5103
"A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer."
Purpose: The purpose of this study is to determine if adding a medication by the name of bevacizumab to the current standard chemotherapy of cancer-reducing medications, namely doxorubicin, cyclophosphamide and paclitaxel, reduces the risk of recurrence (called disease-free survival) compared to standard chemotherapy alone.
Bevacizumab has been approved by the FDA (Food and Drug Administration) for use in the chemotherapy treatment of patients with colorectal cancer. The outcome for those patients showed improvement with the use of this drug. In this study, bevacizumab is considered investigational because it has not received FDA approval for use in breast cancer. Bevacizumab has been studied in previous breast cancer clinical studies. These studies showed improved results in subjects whose breast cancer recurred. Based on these results, it is hoped that using this medication or this type of medication earlier in treatment of the disease may lead to better outcomes for this group of subjects.
Study: CTSU Z1031
"A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women with Clinical Stage II and III Estrogen Receptor Positive Breast Cancer."
Purpose: The purpose of this study is to find out whether it is better to receive exemestane, anastrozole, or letrozole to improve the chance that the breast cancer will get smaller before surgery.
Researchers have been studying breast cancer to learn the best way to treat the disease. Chemotherapy (treatment with anticancer drugs) is commonly given before surgery to shrink breast tumors. The therapy in this research study consists of one of 3 drugs of a type called hormone therapy (a drug used to lower the level of the hormone estrogen). The hormone therapies being tested in this study are exemestane, anastrozole, and letrozole. Research has shown that reducing the amount of the hormone estrogen that gets to the cancer in postmenopausal women with hormone-dependent breast cancer can shrink the breast tumor before surgery.
Study: ECOG PACCT-1
"Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial"
Purpose: This study is for women who have breast cancer that is estrogen receptor and/or progesterone receptor positive and that has not spread to the lymph nodes. Although surgery for this type of cancer is done, there is a chance that the cancer may reoccur in the breast, chest wall, or other parts of the body. Chemotherapy is usually recommended if the risk of recurrence is at least 10% despite hormonal therapy. Approximately 80 - 85% of patients with this stage of disease would be cured with hormonal therapy alone.
This study involves the use of a new diagnostic test called the Oncotype DX. This test will be used to study a section of the cancer tissue taken during surgery. The test uses several small slices of the tumor section. These sections will be analyzed in a specialized laboratory that can measure the levels of a specific group of genes in the tumor. The results of the test are computed into a score (called the Recurrence Score). This Recurrence Score is the likelihood that the cancer will relapse or come back in 10 years.
The purpose of this study is to determine whether subjects who have a tumor with an Oncotype DX Recurrence Score of 11 - 25 benefit from chemotherapy. Also, the study will confirm that most subjects who have Oncotype DX Recurrence Score of less than 10 may be cured with hormonal therapy alone. Additionally, the study will collect follow-up information regarding the health status of all women who participate in the study. This will allow researchers to evaluate new diagnostic tests in the future that may predict benefit or side effects from certain treatments.
Study: IBCSG 24-02
“A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer”
Purpose: This study is being done to see if shutting down the ovaries plus giving tamoxifen is better at preventing the return of breast cancer than just giving tamoxifen alone in premenopausal women. It will also test whether a hormone drug called exemestane plus suppression of the ovaries is better than tamoxifen plus suppression of the ovaries. In addition, the side effects of these different study treatments will be evaluated.
Study: MAP.3
"A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer"
Purpose: Breast cancer is the most common cancer in women, affecting one woman in nine during her lifetime. The risk of developing breast cancer increases with age.
There are certain factors that affect a woman's chance of getting breast cancer. Some of these are: age, family history of breast cancer, number of previous breast biopsies, age at first menstrual period, age at time of first live birth of a child. These factors can be put together to calculate a woman's risk of developing breast cancer. This is called the Gail score. A high Gail score means a woman has a greater risk of getting breast cancer.
Before the study starts, the study doctor will calculate patient's Gail score and explain what it means. If the Gail score is high (greater than 1.66) the study doctor will talk to patients about the use of tamoxifen and raloxifene along with the pros and cons of considering these treatments.
The purpose of this study is to test whether exemestane will reduce the rate of breast cancer in women at high risk for developing the disease. Exemestane is investigational, which means it has not been approved for this use by the U.S. Food and Drug Administration (FDA) or by Health Canada.
In this study, there is a 1 in 2 chance that participants will receive only placebo (a substance that does not do anything). Participants may have concerns about taking part in the study because of this. However, use of placebo is the best way to see if a new therapy is effective and to clearly see the potential side effects and impact on quality of life. The researchers also believe that using a placebo is appropriate because tamoxifen, the approved drug, has not been widely used for preventing breast cancer. Raloxifene is another option that women may consider for breast cancer risk reduction. However, while the risk profile for raloxifene may be better than tamoxifen, it is still associated with increased risk of thromboembolic events (blood clots) and decreased sexual function.
Study: N063D
"ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study: A randomised, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer."
Purpose: The purpose of this study is to find out what effects (good and bad) the study treatment has on patients with HER2/ErbB2 positive breast cancer. Also, it will compare four different study treatment combinations to see if one is better. The study will also find out what effects this study has on patient's quality of life.
Because of recent research by NCCTG, the standard treatment for HER2+ breast cancer now includes trastuzumab (Herceptin®). However, not all patients with HER2+ breast cancer do better with trastuzumab, so investigators are trying to find out why.
GW572016 (lapatinib, brand name: Tykerb®) is a new drug that is taken every day by mouth. Lapatinib is considered "investigational" in this study. "Investigational" means that the FDA has not approved lapatinib as a treatment for early breast cancer.
This study is comparing trastuzumab to lapatinib and each drug alone to two combinations of trastuzumab and lapatinib. The true benefit of taking lapatinib either instead of trastuzumab or with trastuzumab is not known. The four treatments being studied here are:
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Group 1 - The standard treatment - trastuzumab alone for one year
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Group 2 - Lapatinib alone for one year
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Group 3 - Trastuzumab for 12 weeks followed by a 6 week break, and then lapatinib for 34 weeks
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Group 4 - Trastuzumab and lapatinib together for one year
Study: Novartis CZOL446E2352
"A Prospective, Randomized, Double-blind, Stratified, Placebo-controlled, Multi-center, 3-arm Trial of the Continued Efficacy and Safety of Zometa (Every 4 Weeks vs. Every 12 Weeks vs. Placebo) in Patients with Documented Bone Metastases from Breast Cancer"
Purpose: The FDA approval in the United States for patients with bone metastases is for Zometa to be used for 1 year. This study will compare the efficacy of Zometa in dosing schedules beyond one year of every month vs. every 3 months vs. placebo. The reason for this study is to find out whether Zometa continues to decrease skeletal-related events (like breaking bones) after a year and if it does continue to prevent them, and which dose is better (once a month or every 3 months). Another important reason for the study is to look at how safe Zometa is after 1 year.
Study: NSABP B-41
"A Study of AC Followed by a Combination of Paclitaxel Plus Trastuzumab or Lapatinib or Both Given Before Surgery to Patients With Operable HER2 Positive Invasive Breast Cancer"
Purpose: This study is being done to test lapatinib, when given with standard breast cancer treatments. Lapatinib is a new therapy for HER2-positive breast cancer. One way to treat breast cancer is by using chemotherapy drugs. Chemotherapy drugs work by directly killing cancer cells. Another way to treat breast cancer is by using “targeted therapies.” Targeted therapies work by blocking or interfering with a specific part of the cancer cell to slow down or stop the tumor from growing. In this study, all patients will receive the standard chemotherapy drugs doxorubicin and cyclophosphamide (also called AC) followed by paclitaxel (also called Taxol®) before their breast surgery. All patients will also receive a targeted therapy called trastuzumab (also called Herceptin®). Trastuzumab targets a protein called the HER2 protein on the surface of the cancer cell to block the growth signal. The combination of AC followed by paclitaxel and trastuzumab is now a standard way of treating HER2-positive breast cancer.
In addition to the standard treatments, some patients in this study will receive a new drug called lapatinib (also called Tykerb®) before their breast surgery. Lapatinib is a targeted therapy like trastuzumab, but lapatinib works inside the cancer cell to block the HER2 protein.
Study: NSABP B-42
"Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer"
Purpose: This study will look at the effects (good and bad) that letrozole has on postmenopausal women with receptor-positive breast cancer. The main purpose of the study is to learn whether or not continuing hormonal therapy with an AI called letrozole for 5 additional years after already taking 5 years of hormonal therapy (which included an AI) can further reduce the chance of breast cancer returning. Letrozole is investigational (still being researched) for use in subjects who have already received an AI as part of their 5 years of hormonal therapy. Letrozole is considered “investigational” because it has not yet received approval from the U.S. Food and Drug Administration (FDA) or the Canadian Health Products and Food Branch (HPFB) for use after 5 years of hormonal therapy which included an AI.
Another reason for doing this study is to find out whether or not taking the study drug letrozole after taking 5 years of hormonal therapy that included letrozole (or other AI) causes more thinning of bones (osteoporosis) which can cause bones to break more easily. We also want to find out if letrozole increases the chance of heart attack, stroke, and other problems with blood vessels called arteries.
Study: NSABP B-43
"A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy"
Purpose: This study is being done to compare the effects, good and/or bad, of adding the drug trastuzumab (also called Herceptin®) to breast radiation therapy. Radiation therapy is the standard treatment for patients with DCIS.
• This study will find out if adding trastuzumab to breast radiation therapy is more effective than radiation therapy without trastuzumab in preventing occurrence of breast cancer in the same breast, in the other breast, or in other parts of the body in patients with HER2-positive DCIS.
The drug trastuzumab is called a targeted therapy because it targets breast cancers that make too much of a protein called HER2. These cancers are called HER2-positive. Too much of the HER2 protein can cause cells to receive extra growth signals. This can turn a normal cell into a cancer cell and can cause cancer cells to grow faster.
Trastuzumab has been shown to block the HER2 protein and to slow down or stop the growth of HER2-positive “invasive” breast cancers. (“Invasive” means the cancer has spread outside the milk ducts into other parts of the breast or to other parts of the body.)
Also, there is early information that suggests trastuzumab may be a “radiosensitizer”. This means that trastuzumab may help radiation therapy work better in HER2-positive breast cancer. More research is needed to prove this.
In this study, trastuzumab is considered to be investigational (still being researched) because it has not yet been approved by the U.S. Food and Drug Administration (FDA) or Health Canada for use in the treatment of DCIS.
• The only research data on how trastuzumab affects the ovaries in women who have not yet gone through menopause are from studies of trastuzumab given with chemotherapy or after chemotherapy. This study will learn if trastuzumab given without chemotherapy affects the ovaries in women who have not yet gone through menopause.
• Those who join the study, will have special research tests done on their tumor tissue that was removed at the time of their lumpectomy. The results of these tests should provide NSABP researchers with information about how genes in the cancer cells may affect the way HER2-positive DCIS responds to treatment.
Study: SWOG S0221
“Phase III Trial of Continuous Schedule AC + G Vs. Q2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer”
Purpose: The main purpose of this study is to compare the effects (good and bad) of four different treatments (or “regimens”) for breast cancer. All of these treatments include essentially the same drugs given in different ways and on different schedules. All of the treatments use standard, commercially available medicines that are known to be effective for treating breast cancer. The chance that this cancer will return or spread depends on a number of factors. A discussion should take place with the health care provider and/or the study doctor regarding the chances for return or spread in each particular case both with and without various treatments.
Study: SWOG S0307
"Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer"
Purpose: This study is investigational and is being done to find out if adding a drug (a bisphosphonate) to hormonal therapy or chemotherapy will help prevent cancer from spreading to the bones or other parts of the body. The use of these drugs in this study is investigational, which means they have not been approved for this use by the U.S. Food and Drug Administration (FDA). "Bisphosphonates" are a group of drugs that have strong effects on the bones and have been shown to strengthen the bones in many patients who take them.
Study: SWOG S0500
"Treatment Decision Making Based on Blood Levels of Tumor Cells in Women With Metastatic Breast Cancer Receiving Chemotherapy"
Purpose: The purpose of this experimental study is to find out if the CellSearch™ blood test, which identifies tumor cells in the blood, can predict survival outcome in subjects with metastatic breast cancer. These tumor cells are called circulating tumor cells (CTCs). The CellSearch™ blood test may allow doctors to tell if current chemotherapy treatments are not working before signs develop that the cancer is getting worse. This is based upon a prior study that showed that most women with high numbers of CTCs had worsening of their breast cancer within 1 to 3 months. In this prior study, increase in the size of a tumor or spread of cancer in the body was determined by standard clinical tests such as physical examinations, x-rays and scans, and not by the CellSearch™ blood test.
This study will test whether switching to another form of treatment based upon the results of the CellSearch™ blood test helps people live longer. In addition, this study will be used to further confirm results of the prior study, which showed that subjects with less than 5 CTCs before they begin treatment live longer than those with greater than or equal to 5 CTCs.
This study is not testing specific treatments, but rather the way decisions to change current treatments are made. The study will also look at whether women who have elevated CTCs after 3 weeks of chemotherapy have a longer overall survival rate staying on their present treatment, or changing chemotherapy. And the study will examine how CTC counts change with different chemotherapies.
Study: SWOG S0622
"Dasatinib in Treating Patients With Stage IV Breast Cancer That Has Spread to the Bone"
Purpose: Dasatinib is a drug that may be able to slow the growth of breast cancer, and it may be able to prevent breast cancer from spreading to and breaking down bones. This study is investigational and is being done to find out if taking the investigational drug dasatinib by mouth by either of two different dosing schedules will help control this type of cancer and whether it will affect bones. An investigational drug is one that is not approved by the U.S. Food and Drug Administration (FDA).
Study: SWOG S0715
"Randomized Placebo-controlled Trial of Acetyl-L-Carnitine (ALC) For the Prevention of Taxane Induced Neuropahty, Phase III.”
Purpose: The purpose of this study is to compare the effects, good and/or bad, of the dietary supplement Acetyl L-Carnitine (ALC) with placebo (contains no active drug) on neuropathy, to find out which is better. Neuropathy (a side effect of taxane based drugs) is a feeling of pain, numbness, and tingling in the extremities, and a reduced ability for the extremities to function properly. We also want to compare the effects of ALC with placebo on fatigue (a feeling of tiredness), also a side effect of taxane-based drugs. In the study, you will get either ALC or placebo. You will not get both.
GASTROINTESTINAL CANCER STUDIES:
Study: CALGB 80405 (Colon or Rectal)
"A Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU / Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum"
Purpose: This study is being done to evaluate the effects (good and bad) of different regimens of chemotherapy. There are two common combinations of chemotherapy drugs used to treat this type of cancer. One uses 5-fluorouracil (also called 5-FU), leucovorin, and oxaliplatin, and is also called "FOLFOX;" the other combination uses 5-FU, leucovorin, and irinotecan, this combination is also called "FOLFIRI." At the present time, the U.S. Food and Drug Administration (FDA) has approved each of these treatments for colon or rectal cancer. The FDA has also approved the use of a drug called bevacizumab in combination with these chemotherapy regimens. Bevacizumab plus either of these chemotherapy regimens is considered the standard of care for most patients. Cetuximab is an antibody that targets and blocks a specific part of the cancer tumor that is felt to encourage tumor growth, called the EGFR receptor (a protein on the surface of cancer cells that can be activated to stimulate the cell to grow and multiply). About 70% of all colon and rectum tumors have this receptor. Cetuximab is approved by the FDA for the treatment of colorectal cancer in patients who have developed progressive cancer following the use of irinotecan.
The purpose of this study is to determine whether one of the 2 combinations (cetuximab plus chemotherapy or cetuximab plus bevacizumab plus chemotherapy) is better than the combination of bevacizumab with chemotherapy.
Study: ECOG E5202 (Colon)
"Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer"
Purpose: To see if specific biological features (often called tumor markers or markers) found in the colon tumor cells can be used to predict if tumors come back in patients with stage II colon cancer. To compare the effects (good and bad) of a combination of chemotherapy drugs, when given with and without the study drug, bevacizumab, on patients with stage II colon cancer at high-risk for recurrence (return of cancer). To see if adding bevacizumab to the other cancer-fighting agents is better for treating colon cancer patients, who may be at increased risk for recurrence based on the markers shown in their tumor.
To see if adding bevacizumab will help prevent the cancer from coming back. The other chemotherapy drugs given in this study are 5-fluorouracil (5-FU), leucovorin and oxaliplatin.
Study: NCCTG N0147 (Colon)
"A Randomized Phase III Trial of Irinotecan (CPT-11) and / or Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU) / Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer"
Purpose: The study is being done in subjects who have had surgery for colon cancer. It is being done to compare the safety and effectiveness of six different groups of drugs in preventing the return of colon cancer.
These drug combinations, namely cetuximab (C225), irinotecan (CPT-11), and oxalipalatin (OXAL), are considered experimental (investigational) in the stage of colon cancer being studied. The study is also being done to compare the effects of the treatments on quality of life and the side effects in the different groups. The study is also trying to determine if C225 helps prevent cancer from coming back when added to chemotherapy.
Study: NSABP R-04 (Rectal)
"A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with Preoperative Radiation Therapy and Continous Intravenous Infusion (CVI) of 5-Fluorouracil (5-FU) in the Treatment of Patients with Operable Carcinoma of the Rectum"
Purpose: This study is being done to see if taking a drug called capecitabine as a pill, twice a day by mouth during the weeks subjects receive radiation therapy, is as good as the standard treatment with the drug 5-fluorouracil (5-FU) given by continuous intravenous infusion (CVI) during the weeks patients receive radiation therapy. The study will also look at these two different treatment options and obtain important information regarding quality of life for both.
GENITOURINARY CANCER STUDIES:
Study: CTSU C90203 (Prostate)
"A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer."
Purpose: The purpose of this study is to compare the effects (good and bad) of the combination of chemotherapy and hormone therapy followed by radical prostatectomy (surgery to remove the prostate) with radical prostatectomy alone in patients with high-risk prostate cancer to see which is better.
This research is being done because many men with this type of prostate cancer are at risk of having the cancer come back if they are treated only with surgery. The study is trying to find out if giving chemotherapy with hormone therapy before surgery makes the chance of being cured of prostate cancer better.
The study will also assess whether diet or lifestyle predicts how well men do overall with this type of cancer.
Study: CTSU R0524 (Bladder)
"A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab with Daily Irradiation or Paclitaxel alone with Daily Irradiation following Transurethral Surgery for Non-Cystectomy Candidates with Muscle-Invasive Bladder Cancer."
Purpose: The purpose of this study is to find out what effects (good and bad) two cancer drugs combined with external radiation therapy has on this type of cancer. The cancer drugs paclitaxel and trastuzumab used in this study are approved for use with other cancers. However, the use of trastuzumab in bladder cancer is investigational.
The combination of trastuzumab and paclitaxel with radiation for this type of cancer is experimental. All subjects in the study will get paclitaxel. Only subjects with certain test results will also get trastuzumab.
These drugs have been used separately in the treatment of many patients with different kinds of tumors, but this is the first study in humans that is using the combination of trastuzumab, paclitaxel and radiation.
The usual treatment for this type of bladder cancer is surgical removal of the bladder and the surgical construction of an alternative bladder. Many patients may have difficulty undergoing this major surgical procedure. The combination of chemotherapy and radiation may be an effective alternative treatment in patients unable to have surgery.
Study: ECOG E2805 (Kidney)
"A Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma"
Purpose: This research is being done because there is no effective therapy to prevent recurrence of kidney cancer. The study will also determine if either Sunitinib or Sorafenib can prevent recurrence of this type of kidney cancer and will compare the effects (both good and bad) of Sunitinib and the Sorafenib with Placebo (pills that look like the study drugs, but are inactive or do not contain the drug) on people with kidney cancer to see which is better. It is not known whether the benefits of taking either Sunitinib or Sorafenib will outweigh the risks. Both Sorafenib and Sunitinib have been approved by the U.S. Food and Drug Administration (FDA) for use in advanced kidney cancer.
Study: ECOG E3805 (Prostate)
"Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer"
Purpose: The purpose of this study is to determine whether giving docetaxel chemotherapy, at the time hormonal therapy is started and when the hormonal therapy is no longer working, is more effective than giving it only at the time the hormonal therapy is no longer working. Hormonal therapy refers to drugs or surgical procedures such as an orchiectomy used to lower testosterone. This puts prostate cancer into remission in most patients as the testosterone is like a fuel for the cancer. It is the standard to give this as the only treatment for your cancer. Normally chemotherapy is reserved for when a patient’s cancer starts to grow again despite having a low testosterone level. In this study participants will either get docetaxel when starting hormonal therapy or when/if their cancer grows with a low testosterone level. If chemotherapy is given when hormones are started for the first time, chemotherapy may be given when/if the cancer grows back with a low testosterone level. Docetaxel is approved when it is given after the cancer grows back, but it is investigational when it is given at the start of hormonal therapy. An investigational drug is one that is not approved by the U.S. Food and Drug Administration (FDA).
If the disease worsens while participants are on hormone treatments, the study doctor will consider the next treatment carefully. This study plan has asked but not required that the study doctor use docetaxel (a type of chemotherapy) once the disease worsens, even if the participant has received docetaxel when starting hormone therapy. The study doctor may also try another hormone treatment before starting docetaxel chemotherapy.
GYNECOLOGICAL CANCER STUDIES
Study: GOG 0213 (Ovarian)
"A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone r in Combination with Bevacizumab (NSC #704865, IND #7921) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer"
PURPOSE: One purpose of this study is to compare the combination of carboplatin, paclitaxel and bevacizumab to the standard combination of carboplatin and paclitaxel alone. Effectiveness of treatment will be measured in terms of survival, time without evidence of cancer growth and quality of life (wellness and physical functioning).
The second purpose of this study is to determine if a second surgery to remove tumor followed by chemotherapy can increase the time that patients remain disease free. If the study doctors feel that their patients are good candidates for the second surgery they will be randomized to have surgery or not and at the same time they will be randomized to receive one of the two possible chemotherapy combinations.
Randomization means that participants are put into a group by chance. A computer program will place them in one of the study groups. Neither the participants nor their study doctor can choose the group they will be in. Participants will have an equal chance of being placed in either group. If they are not eligible for surgery they can still be randomized to receive chemotherapy. If participants are randomized to receive the surgery it will be performed before they are given chemotherapy. Chemotherapy will not be given until participants recover from the surgery which could take up to six weeks.
Study: GOG 0219 (Cervical)
"Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer"
Purpose: To determine if combining tirapazamine (TPZ) with cisplatin during radiation therapy increases progression-free survival (PFS) compared with cisplatin and radiation therapy. Tirapazamine is an investigational study drug. An investigational drug is one that is not approved by the U.S. Food and Drug Administration (FDA).
HEAD and NECK CANCER STUDIES
-- No studies at this time. Please check back again.
LEUKEMIA CANCER STUDIES:
Study: CTSU E2902 (Acute Myeloid Leukemia)
"A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission after Primary Induction Failure or Patients over Age 60 in First Remission."
Purpose: The purpose of this study is to determine how well the experimental drug called Farnesyl Transferase Inhibitor (FTI) R115777 can keep this type of cancer in remission and to see what side effects (good and bad) the drug causes.
This research is being done because the average time of remission without therapy is 4 months. Even though participants in this study will be currently in remission, there remains a great chance that their leukemia will recur despite the treatment that they have received. There is currently no effective additional therapy to keep this type of cancer in remission.
Study: SWOG S0106 (Acute Myeloid Leukemia)
“A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) Induction Therapy Versus Standard Induction with Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy with Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy for Patients Under Age 56 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)”
Purpose: The main purpose of this study is to find out what effects (good and bad) this treatment has on patients with AML. It will also try to find out if subjects have more time before their leukemia comes back if they get an investigational drug, gemtuzumab ozogamicin (Mylotarg®), along with the usual chemotherapy treatment for acute myeloid leukemia. It will also look at whether or not adding the gemtuzumab ozogamicin (Mylotarg®) to the first chemotherapy treatment will allow more subjects’ conditions to go into remission (no active leukemia).
LUNG CANCER (NON-SMALL CELL) STUDIES:
Study: AC01L08
"A Multi-Center Randomized Phase 2b Study of Cetuximab (Erbitux®) in Combination with Platinum-Based Chemotherapy as First Line Treatment of Patients with Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)."
Purpose: This study is testing the investigational drug, cetuximab, in combination with different chemotherapy drugs for lung cancer. The aim of the study is to determine which of the drug combinations looks most promising for the treatment of your type of disease and should be tested further. The study will also look at what side effects you may have and how you feel when you are receiving treatment. Even after you are no longer receiving treatment, someone from the study will check with you periodically to see how you are doing.
Study: ECOG E1505
"Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Lung Cancer That Was Removed By Surgery"
Purpose: This research is being done because even with the most aggressive after-surgery treatment with chemotherapy, many people still have the lung cancer recur (come back).
The purpose of this study is to determine if adding the new drug bevacizumab to chemotherapy improves the chance for cure for patients who have had surgery for the removal of the lung cancer. We will compare the effects (good and bad) of adding bevacizumab to chemotherapy with standard chemotherapy alone on you and your lung cancer to see which is better at preventing the cancer from coming back.
Study: Exelixis XL184-202
"A Phase 1b/2 Study of XL184 with or without Erlotinib in Subjects with Non-Small Cell Lung Cancer"
Purpose: The purpose of this study is to find the highest doses of XL184 and of the approved drug erlotinib that are able to be tolerated when taken together. Additionally, the study will see if XL184 alone or in combination with erlotinib is effective in shrinking this type of tumor.
In an attempt to determine the highest dose of XL184 that can be safely given in combination with erlotinib, the study will look at what is called the maximum tolerated dose (MTD). To find the MTD, subjects will enter a number of different treatment groups and receive varying combination amounts of XL184 and erlotinib, depending upon when they entered the study. This means that a group of 3 subjects will be enrolled at the starting dose level of XL184 and erlotinib, and if this dose does not cause unacceptable side effects, the next 3 subjects enrolled with receive a higher dose of XL184. As new groups of subjects enter the study, they will get higher and higher doses until unacceptable side effects occur.
The erlotinib dose will also vary depending on when subjects enter the study. They may enter a treatment group where the erlotinib dose is less than the maximum dose currently used to treat patients with non-small cell lung cancer. Neither subjects nor the subject's study doctor can choose what dose will be given. The dose of either erlotinib or XL184 may be lowered during the study if subjects experience unacceptable side effects. In this part of the study, all subjects will receive erlotinib alone for 14 days and then begin using erlotinib and XL184 together for as long as they, in the opinion of the study doctor, continue to experience benefit from the study drugs.
Study: SWOG S0424
"Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men"
Purpose: It is known that smoking causes lung cancer; however, only 1 in 10 people who smoke get the disease. There are also people with lung cancer who have never smoked cigarettes in their life. The purpose of this study is to determine why women are more likely to be diagnosed with certain types of lung cancer than men are, and to see if factors other than smoking may put women at higher risk of lung cancer than men. The study also will assess what factors are associated with lung cancer in men and women who do not smoke.
LUNG CANCER (SMALL CELL) STUDIES:
-- No studies at this time. Please check again.
LYMPHOMA (NON-HODGKIN’S) STUDIES:
Study: CALGB 50303
"Phase III Randomized Study of R-CHOP vs. Dose-Adjusted EPOCH-R with Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas"
Purpose: The purpose of this study is to compare the effects (good and bad) of two treatments (called R-CHOP with Dose-Adjusted EPOCH-R {DA-EPOCH-R, for short}) on people with this type of lymphoma to find out which is better. Currently, R-CHOP is considered standard of care (that is, a treatment that is widely used by most physicians) for this type of lymphoma, while DA-EPOCH-R is an investigational treatment developed over the last 14 years. The drugs involved in this research have all been approved by the FDA. The drugs being used in the DA-EPOCH-R combination have been approved for other cancers, but not in this combination for this type of lymphoma. For this reason, this particular drug combination is investigational.
Another important goal of the study is to analyze the tumors using scientific laboratories to better understand this type of lymphoma.
Study: Eli Lilly H6Q-MC-JCBJ
"PRELUDE: A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin."
Purpose: The primary purpose of this study is to help answer the following research questions:
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Whether enzastaurin can help people with Diffuse Large B Cell Lymphoma remain free from disease and thus live longer.
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Whether enzastaurin is safe and what are the bad effects that might be associated with it.
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To assess the health changes of subjects with lymphoma while receiving enzastaurin.
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To look at certain genes or proteins in subjects blood and tumor tissue to learn more about lymphoma and how enzastaurin works in their body.
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To look at the level of enzastaurin in subjects body and how long it remains.
LYMPHOMA (HODGKIN’S DISEASE) STUDIES:
-- No studies at this time. Please check again.
MELANOMA CANCER STUDIES:
-- No studies at this time. Please check again.
MYELOMA STUDIES:
Study: CTSU E1A05
"Randomized Phase III Trial of Consolidation Therapy with Bortezomib (Velcade®)- Lenalidomide (Revlimid®) -Dexamethasone (VRD) versus Bortezomib (Velcade®) -Dexamethasone (VD) for Patients With Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen"
Purpose: The purpose of this study is to find out what effects (good and bad) that two combinations of drugs have on Patients with Multiple Myeloma and to find out which treatment is better. In this study subjects will be selected to receive one of two treatments, either bortezomib, lenalidomide and dexamethasone, or bortezomib and dexamethasone. They will not receive both treatments.
Lenalidomide (CC-5013) and bortezomib have been approved by the FDA for the treatment of multiple myeloma in patients who have failed at least one prior therapy; lenalidomide has also been approved for the treatment of a rare bone marrow disorder called 5q- myelodysplastic syndrome. The experimental treatment in this study is to test novel agent combinations as an alternative to stem cell transplantation. The use of bortezomib, lenalidomide and dexamethasone in this stage of myeloma is also considered experimental. Both lenalidomide and bortezomib target myeloma cells directly and cause these cells to die.
Study SWOG S0777
“A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant.”
Purpose: The purpose of this study is to compare the effects, good and/or bad, of a two-drug combination (CC-5013 [lenalidomide] and low dose dexamethasone, also called “LLD”) with a three-drug combination (CC-5013 [lenalidomide], low dose dexamethasone, and a new drug called bortezomib ([Velcade®], also called “BLLD”). CC-5013 (lenalidomide) and bortezomib are both experimental drugs. We are comparing these two different combinations of drugs to evaluate whether they can stop or slow down the progression of this type of cancer, and if so, which one is more effective.
SARCOMA STUDIES:
Study: J & J ET743-SAR-3002--for more information contact one of the Cancer Research Nurses at Providence: (907) 212-5016.
"A Multicenter, Open-Label Single-Arm Study of YONDELIS® (trabectedin) for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment"
Purpose: The purpose of this research study is to provide an experimental drug, trabectedin, to eligible, previously treated- people with soft tissue sarcoma. The safety of trabectedin will also be evaluated during this study. Trabectedin is investigational, which means that it is not approved for sale by the Food and Drug Administration (FDA), or by any other regulatory agencies but is being studied in several other illnesses in addition to soft tissue sarcoma.
MISCELLANEOUS STUDIES:
Study SWOG S0702
“A prospective observational multicenter cohort study to assess the incidence of osteonecrosis of the jaw (ONJ) in cancer patients with bone metastases starting zoledronic acid treatment. ”
Purpose: The purpose of this study is to learn how often ONJ occurs in patients who are being treated with zoledronic acid during a 3 year time period after starting treatment. This study will also identify risk factors associated with ONJ.
Zoledronic acid falls under a category of drugs called bisphosphonates. Bisphosphonates are sometimes given to patients who have cancer that has spread to their bones because it can lower the chances of getting fractures and reduces bone pain. Usually, zoledronic acid is well tolerated by patients, but there has been an increase in the number of reported cases of osteonecrosis of the jaw (ONJ). Symptoms associated with ONJ are swelling of the soft tissue around the jaw, infection, loosening of teeth, drainage, and exposed jaw bone. There is concern about the association of ONJ with bisphosphonate therapy.
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