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Study 18 of 884 for search of: | United States, Delaware |
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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00217737 |
RATIONALE: 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 combination chemotherapy together with bevacizumab after surgery may kill any remaining tumor cells or prevent the cancer from coming back. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone or observation only in treating colon cancer.
PURPOSE: This randomized phase III trial is studying oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil or observation only in treating patients who have undergone surgery for stage II colon cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: bevacizumab Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: observation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin Versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers |
Estimated Enrollment: | 3610 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV bolus followed by fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses.
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Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
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Arm II: Experimental
Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses.
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Drug: bevacizumab
Given IV
Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
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Arm III: No Intervention
Patients undergo observation only.
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Procedure: observation
No intervention
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are stratified according to disease stage (IIA vs IIB) and microsatellite stability (MSS) (stable vs low-grade instability [MSI-L]). Patients with disease that is at high risk for microsatellite instability (MSI) and loss of heterozygosity (LOH) at chromosome 18q are randomized to 1 of 2 treatment arms (arms I and II). Patients with disease that is at low risk for MSI and 18q LOH are assigned to arm III.
PROJECTED ACCRUAL: A total of 3,610 patients will be accrued for this study within 5.8 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
Stage II disease (T3-4, N0, M0)
Meets 1 of the following criteria:
High risk for microsatellite instability (MSI) and loss of heterozygosity (LOH) at chromosome 18q
Low risk for MSI and 18q LOH
Distal extent of tumor must be ≥ 12 cm from the anal verge by endoscopy or surgical examination
Has undergone surgical resection of the tumor between the past 28-60 days
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
PT INR > 1.5* allowed provided the following criteria are met:
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Al B. Benson, MD, FACP | Robert H. Lurie Cancer Center |
Investigator: | Peter J. O'Dwyer, MD, BCh | University of Pennsylvania |
Study ID Numbers: | CDR0000443410, ECOG-E5202 |
Study First Received: | September 20, 2005 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00217737 |
Health Authority: | Unspecified |
adenocarcinoma of the colon stage II colon cancer |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Leucovorin Bevacizumab Intestinal Diseases Rectal Diseases Recurrence Intestinal Neoplasms |
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 |