Colorectal Clinical Research Trials
Name of Study: CALGB/SWOG C80405
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 and Rectum. Principal Investigator: R. Mena, M.D. Nature and Purpose of Study
Patients asked to take part in this study have cancer of the colon or rectum which has spread and has not yet been treated. Background
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 your 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 Food and Drug Administration (FDA) has approved each of these as treatment for colon or rectal cancer. The FDA has also approved the use of a drug called bevacizumab (or Avastin) in combination with these chemotherapy regimens. Bevacizumab plus either of these chemotherapy regimens is considered the standard of care for most patients. Cetuximab (or Erbitux) 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). Although not all colon and rectum tumors have this receptor, 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 following two combinations: cetuximab plus chemotherapy, or cetuximab plus bevacizumab plus chemotherapy, is better than the combination of bevacizumab with chemotherapy.
back to top Name of Study: CTSU N0147
A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer. Principal Investigator: R. Mena, M.D. Nature and Purpose of Study
This study is being done in patients who have had surgery for colon cancer. Background
The study is being done to: - Find out if adding C225 to FOLFOX (a combination of the 3 drugs oxaliplatin, leucovorin and 5-fluorouracil) increases the effectiveness of FOLFOX in preventing your colon cancer from coming back.
- See whether patients get better results in one of these groups.
- Compare the side effects in the two groups of patients in the study.
- Compare the effects of treatment on your quality of life (changes to daily routines and feelings of overall health).
- See if there is any interaction between such things as your lifestyle habits, medication use or dietary patterns and the molecular markers contained within your tumor.
- See if your eating habits affect the chances of your cancer coming back.
- We will look at markers in tissue or blood specimens obtained from you to determine whether these markers can be used to predict whether your tumor responds to chemotherapy or the chance that your cancer will come back. These studies are for research purposes and have not been accepted into routine medical practice.
C225 is being used in this studyto see if it helps prevent cancer from coming back when added to chemotherapy. It is not possible at this time to know whether your participation in this study will prevent your cancer from coming back.
back to top Name of Study: SWOG 0600
Phase III Trial of Irinotecan-based Chemotherapy Plus Cetuximab with or without Bevacizumab as Second-Line Therapy for Patients with Metastatic Colorectal Cancer who have Progressed on Bevacizumab with Either FOLFOX, OPTIMOX or XELOX. Principal Investigator: R. Mena, M.D. Nature and Purpose of Study
Patients asked to take part in this study have colorectal cancer that has spread and that has not responded to prior treatment that included bevacizumab. Background
The purpose of this study is to compare the effects, good and/or bad, of not adding bevacizumab or of adding either a lower dose or a higher dose of bevacizumab to cetuximab plus an irinotecan-based treatment. We want to know the effects of these doses on you and your colorectal cancer to find out which is better. Bevacizumab is considered investigational in this study. The other drugs used in this study are not considered investigational. Bevacizumab is the common name for the commercial drug Avastin. The bevacizumab used in this trial, however, is for use in research studies only and may be made at locations different from those where Avastin is made. Although some differences may exist, bevacizumab for research use and the commercial drug, Avastin, are manufactured by a similar process, meet similar standards for final product testing, and are expected to be very similar in safety and effectiveness.
back to top Name of Study: CTSU CALGB 80101
Phase III Trial of Adjuvant Chemoradiation after Resection of Gastric or Gastroesophageal Adenocarcinoma. Principal Investigator: R. Mena, M.D. Nature and Purpose of Study
Usually, this type of cancer is treated with surgery to remove the tumor, followed by treatment with chemotherapy plus radiation therapy. This treatment plan has been established by other research of patients who have similar cancers. In some patients, giving chemotherapy drugs and radiation therapy after surgery can reduce the risk of the cancer coming back. Background
The Cancer and Leukemia Group B (CALGB), in cooperation with other cancer researchers, is trying to develop better treatments for stomach cancer which would result in fewer patients having their cancer come back. One approach being studied is the use of newer chemotherapy combinations. A recent study found that patients who received the drugs 5-fluorouracil (5-FU) and leucovorin in combination with radiation therapy after surgical removal of a stomach cancer had a lower risk of the cancer coming back. This is the drug combination that is most commonly used for people with your type of cancer. However, the drug combination of Epirubicin, Cisplatin and 5-FU followed by the continuous intravenous infusion of 5-FU chemotherapy with radiation therapy has been offered as a new approach to for patients after a surgical removal of stomach cancer. Currently, it is not know which of these two treatments is more effective. The purpose of this study is to determine which of the following combinations of chemotherapy and radiation are more effective in preventing the return of your stomach cancer: - A schedule of chemotherapy drugs called fluorouracil (5-FU) and leucovorin in combination with radiation therapy, or:
- A schedule of chemotherapy drugs called epirubicin, cisplatin, and fluorouracil (5-FU) in combination with radiation therapy. (This regimen is called ECF).
The purpose of this study is to find out what effects (good and bad) the combination of epirubicin, cisplatin, and 5-FU (all commercially available) plus 5-FU with radiation therapy to the abdomen will have in the treatment of stomach cancer.
back to top Name of Study: S0425
"Neoadjuvant Chemoradiation Therapy with Oxaliplatin and Capecitabine for Patients with Surgically Resectable Gastric Cancer: A Pilot Phase II Trial with Molecular Correlates". Principal Investigator: R. Mena, M.D. Nature and Purpose of Study
The purpose of this study is to find out what are the effects (good and bad) of being treated with oxaliplatin, capecitabine and radiation therapy before surgery for gastric cancer. Background
This study is unique because usually chemotherapy and radiation are given after surgery for gastric cancer. In this study chemotherapy and radiation will be given before surgery. This strategy has several advantages including reduction in the size of tumor, which may make it easier to remove all of the cancer during surgery. In addition, when chemotherapy and radiation are planned for after surgery, not all patients have fully recovered from surgery and are unable to receive this therapy. When chemotherapy and radiation are given before surgery all patients may potentially receive the planned therapies. This research is being done because we want to find a more effective treatment for this type of cancer. We want to know whether treatment with oxaliplatin, capecitabine and radiation therapy before surgery will increase the chance that the surgeon can remove all the cancer during surgery. Oxaliplatin and capecitabine have not previously been used for potentially resectable gastric cancer. However, preliminary reports in patients with advanced gastric cancer have demonstrated very good response rates. We are hopeful similar response rates will be seen in patients with early gastric cancer.
back to top Name of Study: NSABP R-04
Treatment with Two Chemotherapy Drugs Combined with Radiation Therapy for Patients with Rectal Cancer . Principal Investigator: R. Mena, M.D. Nature and Purpose of Study
Patients asked to take part in this study have rectal cancer. At this time, it is thought that the best way to treat this cancer is to provide treatment with drugs (chemotherapy) and radiation (radiotherapy) to try to shrink the tumor. After chemotherapy and radiotherapy, patients will have surgery to remove any tumor that is left. Background
This study is being done to see if taking a drug called capecitabine as a pill, twice a day by mouth during the weeks you receive radiation therapy, is as good as the standard treatment with the drug 5-fluorouracil (5-FU) given continuously into your vein during the weeks you receive radiation therapy. This study will look at two different treatment options and obtain important information regarding quality of life for both. At this time we do not know which chemotherapy drug, when combined with radiation therapy, is better for the type of cancer you have. The final reason for doing this study is that the U.S. Food and Drug Administration (FDA) considers the use of capecitabine to be investigational for cancer such as yours. Capecitabine in combination with radiotherapy must be tested further in patients with your type of cancer.
back to top Name of Study: E5204
Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-operative Chemoradiation. Principal Investigator: R. Mena, M.D. Nature and Purpose of Study
Patients asked to take part in this study have rectal cancer and have already received chemotherapy, radiation and surgery for the disease. Background
This study will compare the overall survival in patients with clinical stage II and stage III rectal cancer who received preoperative chemoradiation and surgery and will compare the investigational treatment combination of oxaliplatin, fluorouracil and leucovorin with or without bevacizumab. The standard of care for patients with stage III colon cancer is post-surgery chemotherapy with oxaliplatin, fluorouracil and leucovorin; however, this therapy has not been evaluated in patients with surgically-removed rectal cancer. The chemotherapy regimen chosen for this study is based on the results of the colon cancer adjuvant studies with the same drugs. The chemotherapy drugs given in this study are 5-fluorouracil (5-FU), leucovorin and oxaliplatin. We want to see if adding bevacizumab to the other cancer-fighting agents is better for treating rectal cancer patients. We also want to see if adding bevacizumab will help prevent the cancer from coming back. Bevacizumab is the common name for the commercial drug, Avastin. The bevacizumab used in this trial, however, is for use in research studies only and may be made at different locations from those where Avastin is made. Although some differences may exist, bevacizumab for research use and the commercial drug, Avastin, are manufactured by a similar process, meet similar standards for final product testing and are expected to be very similar in safety and effectiveness.
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Pancreatic Clinical Research Trials
Name of Study: A4061028
A Randomized, Double-blind Phase 3 Study of Gemcitabine Plus AG-013736 Verses Gemcitabine plus Placebo for the First-line Treatment of Patients with Locally Advanced, Unresectable or Metastatic Pancreatic Cancer. Principal Investigator: M. Berkowitz, M.D. Nature and Purpose of Study
Patients eligible for this study have a cancer of the pancreas that is locally advanced or has spread to other parts of your body. Background
This is a study of an investigational cancer drug, AG-013736, run by Pfizer Inc. AG 013736 is not yet approved for sale. Cancer needs blood vessels to grow and AG-013736 may work by preventing growth of new blood vessels within cancer. AG-013736 has been given to over 500 cancer patients. In a previous study, 77 patients with pancreatic cancer have received AG 013736 together with gemcitabine. Gemcitabine is a standard chemotherapy, approved for treatment of pancreatic cancer. The main purpose of this study is to determine whether AG-013736 plus gemcitabine help patients live longer compared to gemcitabine alone. Other purposes are to determine whether AG-013736 plus gemcitabine helps to keep cancer from growing, how well the tumors shrink, how well patients tolerate the drug, to measure the amount of AG-013736 in your blood, and to evaluate drug metabolizing enzymes.
back to top Name of Study: CTSU E2204
An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination with Gemcitabine and in Combination with Chemoradiation (Capecitabine and Radiation) in Patients with Completely-Resected Pancreatic Carcinoma. Principal Investigator: R.Mena, M.D. Nature and Purpose of Study
Patients taking part in this study have pancreas cancer and have had surgery to remove the cancer. Background
The purpose of this study is to test the safety and side effects of two new drugs, bevacizumab (anti-VEGF) or cetuximab (Erbitux, C225), in combination with gemcitabine and in combination with chemoradiation (capecitabine and radiation) for patients with resected (surgically removed) pancreas cancer. In addition, this study will test the safety of using capecitabine (Xeloda), a pill form of chemotherapy, with radiation for patients with resected pancreas cancer. Bevacizumab is the common name for the commercial drug Avastin. The bevacizumab used in this trial, however, is for use in research studies only and may be made at locations different from those where Avastin is made. Although some differences may exist, bevacizumab for research use and the commercial drug, Avastin, are manufactured by a similar process, meet similar standards for final product testing, and are expected to be very similar in safety and effectiveness. Bevacizumab and cetuximab are considered investigational and have not been approved by the FDA for use in pancreas cancer. Capecitabine is a drug that has been used to effectively treat certain cancers and has been approved by the FDA for use in the treatment of patients with breast and colon cancer. The purpose of this study to see if it may also be a safe and effective treatment when combined with radiation therapy and other drugs for patients with cancer of the pancreas. A recent randomized clinical trial for patients with advanced pancreatic cancer (cancer that cannot be removed with surgery) was stopped because it did not appear likely that patients who were receiving bevacizumab with gemcitabine would live any longer than those who were receiving gemcitabine alone. However, we do not know whether or not bevacizumab in combination with gemcitabine and chemoradiation will help patients whose cancer can be removed completely with surgery, as is the case in this study.
back to top Name of Study: EFC6596
A Randomized, Open Label Multi-Center Study of Single Agent Larotaxel (XRP9881) Compared To Continuous Administration Of 5-FU For The Treatment of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen. Principal Investigator: M. Berkowitz, M.D. Nature and Purpose of Study
Participants in this clinical research study have pancreatic cancer, and no longer benefit from treatment with gemcitabine (Gemzar®). Additinally, the patient’s physician has determined that further treatment for cancer is necessary. Background
Continuous administration of oral capecitabine is a chemotherapeutic option for the treatment of your disease. Larotaxel (XRP9881) is a new research drug that is being offered to you as part of this clinical study. Larotaxel has been given to more than 800 patients so far, mainly suffering from breast cancer. The purpose of this clinical study is to determine if larotaxel is better treatment than continuous administration of capecitabine for advanced pancreatic cancer in patients who no longer benefit from gemcitabine.
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Prostate Clinical Research Trials
Name of Study: RTOG 0232
A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy with Brachytherapy Alone for Selected Patients with Intermediate Risk Prostatic Carcinoma.
Principal Investigator: N. Ellerbrook, M.D. Nature and Purpose of Study
The purpose of this study is to compare the effects – both good and bad – of two different radiation treatments in patients with prostate cancer. The effects of placing small radioactive pellets (hereinafter called “seeds”) inside the prostate (brachytherapy) after external radiation therapy will be compared to the effects of using brachytherapy alone in patients with prostate cancer. Background
This research is being done to see which treatment is better. This study will also look at your already biopsied prostate cancer tissue for information that may help to predict and treat prostate cancer in the future. In addition, the study will gather information about the effects of the treatment on your quality of life. A cost comparison between the two treatments, including long term costs thereafter, is also planned for participants under Medicare.
back to top Name of Study: RTOG 0521
A Phase III Protocol of Androgen Suppression (AS) and 3D CRT/IMRT vs AS and 3D CRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostatic Carcinoma. Principal Investigator: M. Hyman, M.D. Nature and Purpose of Study
The main purpose of this study is to try to find out whether adding chemotherapy to the standard treatment for a particular stage of prostate cancer is more effective than the standard treatment by itself. Background
The kind of treatment that most physicians would consider standard for this stage of prostate cancer combines radiation therapy and hormones. In this study all patients will receive both of these. In addition, half the patients will also receive chemotherapy drugs for about four to five months. It is hoped that chemotherapy will be found to provide additional benefit, but chemotherapy has significant side effects. The use of chemotherapy is experimental in prostate cancer; it needs to be tested to determine if it is beneficial and to find out more about the side effects of the two different treatments.
back to top Name of Study: SWOG 9346
Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer, Phase III. Principal Investigator: R. Mena, M.D. Nature and Purpose of Study
Participants in this research study have cancer of the prostate that has spread to other parts of the body. Background
This study seeks to find out how well patients respond to different methods of giving treatment with an LHRH analogue in conjunction with an antiandrogen drug. For patients treated in the United States (except EPP Institutions) and treated through the European Organization for the Research and Treatment of Cancer, the specific drugs used will be Zoladex™ and Casodex™. If treatment works in your case, it may shrink your tumor or cause it to disappear, and/or prolong your life and/or improve the quality of your life. We also want to find out what kind of side effects this treatment causes and how often they occur. We also want to find out what the quality of life for patients is according to the type of treatment received on this study. Treatment for prostate cancer can affect any one of the following areas of your life. Treatment may affect the way you feel physically, emotionally, or the way you interact with other people. You may have some general symptoms or symptoms commonly associated with prostate cancer treatment. Your treatment may affect your general health and your quality of life. It is very important to have your view about how you have been feeling during your treatment. In this way, we can gather information that can, in the future, help a doctor and patient make treatment decisions. If you complete a questionnaire on a regularly scheduled basis as described below, you will help describe the effect on quality of life in the specific treatment you receive. The best way to measure the quality of life for prostate cancer patients is not known. One of the goals of these studies is to determine the effect of treatment on the patient's quality of life.
back to top Name of Study: CTSU E3805
CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease Prostate Cancer. Version 01/02/07. Principal Investigator: M.Berkowitz, M.D. Nature and Purpose of Study
The purpose of this study is to determine whether giving docetaxel chemotherapy, at the time a patient begins hormonal therapy 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. Background
Hormonal therapy refers to drugs or surgical procedures such as an orchiectomy used to lower your 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 you will either get docetaxel when you start your hormonal therapy or when/if your cancer grows with a low testosterone level. If you have chemotherapy when you start hormones for the first time, you may get chemotherapy when/if your cancer grows back with a low testosterone level. If your disease worsens while you are on hormone treatments, your doctor will consider your next treatment very carefully. This protocol has asked but not required that your doctor use docetaxel (a type of chemotherapy) once your disease worsens, even if you had received docetaxel when you started hormone therapy. Your doctor may also try another hormone treatment before starting you on docetaxel chemotherapy. The purpose of this study is to determine whether receiving docetaxel both when you start hormone therapy (or within 90 days of beginning hormonal therapy) as well as when your disease worsens, is better than only receiving docetaxel when your disease gets worse. This trial will let us know which approach is more effective in treating your disease.
back to top Name of Study: CTSU/CALGB 90202
A Randomized, Double-Blind, Placebo-Controlled Phase III Study Of Early Versus Standard Zoledronic Acid To Prevent Skeletal Related Events In Men With Prostate Cancer Metastatic To Bone. Principal Investigator: R. Mena, M.D. Nature and Purpose of Study
The purpose of this study is to compare the effects – both good and bad – of early treatment with zoledronic acid (Zometa) compared to standard treatment with zoledronic acid. Background
We know that treatment with zoledronic acid decreases the risk of certain skeletal (bone) related events in men with prostate cancer AFTER the cancer has spread to the bones and continues to grow even with hormonal therapy (standard treatment). This research is being done because we do not know whether earlier treatment with zoledronic acid (started BEFORE the cancer grows with hormonal therapy) is better or worse than standard treatment.
back to top Name of Study: CTSU/CALGB 90203
A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostectomy Versus Immediate Radical Prostectomy in Patients with High-Risk, Clinically Localized Prostate Cancer. Principal Investigator: M. Berkowitz, M.D. Nature and Purpose of Study
Participants in this study have prostate cancer and are at risk of cancer recurrence after surgery to remove the prostate. The patient is at increased risk for cancer recurrence because of a PSA (prostate specific antigen) blood test, prostate biopsy Gleason score (the way your cancer looks under a microscope), and/or the clinical stage. Background
The purpose of this study is to compare the effects – both good and bad – of the combination of chemotherapy and hormone therapy followed by radical prostatectomy (surgery to remove your prostate) with radical prostatectomy alone on you and your prostate cancer to see which is better. This research is being done because many men with your type of prostate cancer are at risk of having the cancer come back if they are treated only with surgery. We are trying to find out if giving chemotherapy with hormone therapy before surgery makes the chance of being cured of prostate cancer better. We are also going to study whether anything in your diet or lifestyle predicts how well you do overall with your cancer.
back to top Name of Study: EFC6546/Venice
A Multicenter Randomized, Double-Blind Study Comparing the Efficacy & Safety of Aflibercept vs Placebo Administered Every 3 Weeks in Patients Treated w/ Docetaxel/Prednisone for Metastatic Androgen-Independent Prostate Cancer. Principal Investigator: M. Berkowitz, M.D. Nature and Purpose of Study
To be eligible for this study, the patient’s doctor has determined that treatment with docetaxel [TAXOTERE®], a drug that is already approved for use in prostate cancer, is necessary for the treatment of the disease. Patients are invited to participate in this clinical research study evaluating docetaxel alone or in combination with a new experimental drug called Aflibercept. Aflibercept is an investigational drug that is being tested and is not approved for use in the United States by the U.S. Food and Drug Administration (FDA). Background
Aflibercept is already under evaluation in approximately 500 patients with various tumors and various chemotherapy combinations. A specific study to find the correct dose and to evaluate the safety of the combination of docetaxel and aflibercept has already been done. In that study, 27 patients with various tumors were treated and from the results of that study, the dose 6 mg per kilogram (kg), was selected to be used for this study. The purpose of this clinical study is to determine if aflibercept is better than placebo (an inactive substance), in combination with docetaxel [TAXOTERE®] for your disease.
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