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  • 14T-MC-JVBB - A Randomized, Double-Blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients with Metastatic, Colorectal Carcinoma Progressive or Following First-Line Combination Therapy with Bevacizumab, Oxaliplatin, and a Fluoropyrimidine. Accrual limited to Abington Cancer Care Specialists.

    Rationale: The investigational drug used in this study may stop the growth of tumor cells by blocking its supply of nutrients and oxygen. It can be combined with chemotherapy drugs, which work in different ways to stop the growth of tumor cells. It is not yet known whether the investigational agent used in this study when given in combination with chemotherapy is more effective than chemotherapy alone for the treatment of metastatic colorectal cancer. Purpose: The purpose of this study is to determine whether this investigational drug can help colorectal cancer patients live longer when it is given with chemotherapy treatment (FOLFIRI). The study will include only patients who have already been treated with chemotherapy but who have progressed, either while being treated, or after completion of treatment. The study will also include genetic testing which will help researchers to better understand which patients might benefit from this investigational drug in the future. (NCT01183780)

  • CALGB/SWOG – C80405 – A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225) for Patients with Untreated Metatastic Adenocarcinoma of the Colon or Rectum (Note: This new study title reflects removal of Arm C.)

    Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with cetuximab and/or bevacizumab in treating patients with colorectal cancer. This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer. (NCT00265850)

  • ECOG E4203 - Phase II Study of Treatment Selection Based Upon Tumor Thymidylate Synthaase Expression in Previously Untreated Patients with Metastatic Colorectal Cancer (Arm C remains suspended for response evaluation).

    Drugs used in chemotherapy, such as oxaliplatin, irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving bevacizumab together with combination chemotherapy may be a better way to block tumor growth. Studying the amount of an enzyme found in the tumor may help doctors plan the best treatment. This randomized phase II trial is studying giving bevacizumab, oxaliplatin, and irinotecan or giving bevacizumab, oxaliplatin, leucovorin, and fluorouracil in treating patients with metastatic or recurrent colorectal cancer. (NCT0098787)

  • ECOG 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 .

    Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating rectal cancer. This randomized phase III trial is studying combination chemotherapy to see how well it works with or without bevacizumab in treating patients who have had surgery for stage II or stage III rectal cancer. (NCT00303628)

  • NSABP C-11 - A Phase III Study Evaluating the Role of Perioperative Chemotherapy in Patients with Potentially Resectable Hepatic Colorectal Metastases.

    Drugs used in chemotherapy work in different ways to kill tumor cells or stop them from growing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab and combination chemotherapy together before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any remaining tumor cells. It is not yet known whether giving bevacizumab and combination chemotherapy together after surgery is more effective than giving them together before and after surgery. This randomized phase III trial is studying giving combination chemotherapy and bevacizumab together before and after surgery to see how well it works compared to giving combination chemotherapy and bevacizumab together after surgery in treating patients with colorectal cancer with liver metastases that could be removed by surgery. (NCT01189227)

  • NSABP P-5 - Statin Polyp Prevention Trial in Patients with Resected Colon Cancer.

    RATIONALE: Rosuvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving rosuvastatin after surgery may kill any tumor cells that remain after surgery. It may also keep polyps from forming or colon cancer from coming back. It is not yet known whether rosuvastatin is more effective than a placebo in treating colon cancer that was removed by surgery. This randomized phase III trial is studying rosuvastatin to see how well it works compared with placebo in treating patients with stage I or stage II colon cancer that was removed by surgery. (NCT01011478)

  • RTOG - 0822 - A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) In Combination With Capecitabine & Oxaliplatin For Patients With Locally Advanced Rectal Cancer.

    Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. This phase II trial is studying the side effects and how well giving combination chemotherapy together with intensity-modulated radiation therapy works in treating patients undergoing surgery for locally advanced rectal cancer. (NCT00613080)

  • SWOG S0600 - Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) with or without Bevacizumab (NSC-704865) as Second Line therapy for Patients with Metastatic Colorectal Cancer who have Progressed on Bevacizumab with either FOLFOX, OPTIMOX, or XELOX (Accrual suspended 6/6/08).

    Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether irinotecan and cetuximab are more effective with or without bevacizumab in treating metastatic colorectal cancer. This randomized phase III trial is studying giving irinotecan and cetuximab together with bevacizumab to see how well it works compared with giving irinotecan and cetuximab alone in treating patients with metastatic colorectal cancer that progressed during first-line therapy. (NCT00499369)

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