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Study 18 of 223 for search of: | United States, Alaska |
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Sponsors and Collaborators: |
National Surgical Adjuvant Breast and Bowel Project (NSABP) National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00096278 |
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Giving chemotherapy together with bevacizumab may kill more tumor cells. It is not yet known whether treatment with oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating patients who have undergone surgery for colon cancer.
PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin, and fluorouracil together with bevacizumab to see how well it works compared to oxaliplatin, leucovorin, and fluorouracil alone in treating patients who have undergone surgery for stage II or stage III colon cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: FOLFOX regimen Drug: bevacizumab Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Clinical Trial Comparing Infusional 5-Fluorouracil (5-FU), Leucovorin, and Oxaliplatin (mFOLFOX6) Every Two Weeks With Bevacizumab to the Same Regimen Without Bevacizumab for the Treatment of Patients With Resected Stages II and III Carcinoma of the Colon |
Estimated Enrollment: | 2632 |
Study Start Date: | September 2004 |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and number of positive lymph nodes (0 vs 1-3 vs > 3). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 2,632 patients (1,316 per treatment arm) will be accrued for this study within 2.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon, meeting 1 of the following stage criteria:
No rectal tumors
T4 tumors involving an adjacent structure (e.g., bladder, small intestine, or ovary) by direct extension from the primary tumor are eligible provided the following criteria are met:
En bloc complete gross resection of tumor by open laparotomy or laparoscopically-assisted colectomy within the past 29-50 days
Patients with > 1 synchronous primary colon tumor are eligible
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
AST < 1.5 times ULN
No PT/INR > 1.5 unless patient is on full-dose anticoagulants AND the following criteria are met:
Renal
Cardiovascular
No cardiovascular disease that would preclude study participation, including any of the following:
Other
No other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Carmen J. Allegra, MD | Network for Medical Communication and Research |
Study ID Numbers: | CDR0000390343, NSABP-C-08 |
Study First Received: | November 9, 2004 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00096278 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the colon stage II colon cancer stage III colon cancer |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Leucovorin Bevacizumab Intestinal Diseases Rectal Diseases Intestinal Neoplasms Carcinoma |
Calcium, Dietary Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Colonic Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Growth Inhibitors Angiogenesis Modulating Agents Micronutrients |