Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Institut Bergonie |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00467142 |
RATIONALE: 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. Drugs used in chemotherapy, such as 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. Giving bevacizumab together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: bevacizumab Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Procedure: polymorphism analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | Phase II Study Evaluating the Efficacy and Tolerance to Chemotherapy With 5-Fluorouracil, Folinic Acid, Irinotecan and Bevacizumab as First-Line Treatment in Patients With Metastatic Colorectal Cancer |
Estimated Enrollment: | 61 |
Study Start Date: | November 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and bevacizumab IV on day 1. Patients also receive fluorouracil IV over 46 hours beginning on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
Blood and tissue samples are collected periodically for pharmacogenetic and genetic polymorphism analysis.
PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.
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 or rectum
Metastatic, unresectable disease
PATIENT CHARACTERISTICS:
No thromboembolic arterial condition in the past 6 months, including any of the following:
No condition that is unstable or would increase risk to the patient, including any of the following:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000540522, IB-2006-31, IB-OMEGA, INCA-RECF0387, EUDRACT-2006-003901-22 |
Study First Received: | April 25, 2007 |
Last Updated: | January 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00467142 |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon |
adenocarcinoma of the rectum recurrent colon cancer recurrent rectal cancer |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases Leucovorin Bevacizumab Intestinal Diseases Rectal Diseases Camptothecin |
Recurrence Intestinal Neoplasms Rectal neoplasm Calcium, Dietary Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Growth Inhibitors Angiogenesis Modulating Agents Micronutrients Antineoplastic Agents, Phytogenic |