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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077298 |
RATIONALE: Monoclonal antibodies such as cetuximab and bevacizumab can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as irinotecan, also work in different ways to kill cancer cells or stop them from growing. Giving cetuximab and bevacizumab together with irinotecan may improve the ability to block cancer growth.
PURPOSE: This randomized phase II trial is studying giving bevacizumab and cetuximab together with irinotecan to see how well it works compared to giving bevacizumab and cetuximab alone in treating patients with irinotecan-refractory metastatic colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Biological: bevacizumab Biological: cetuximab Drug: irinotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase II Study Of Bevacizumab In Combination With Cetuximab Plus Irinotecan, Or In Combination With Cetuximab Alone, In Irinotecan Refractory Colorectal Cancer |
Study Start Date: | December 2003 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 vs 1), and albumin (> 3.0 g/dL vs ≤ 3.0 g/dL). Patients are randomized to 1 of 2 treatment arms.
NOTE: *Bevacizumab is given on day 2 (instead of day 1) of course 1, and is given on day 1 of subsequent courses.
In both arms, courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) 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 or cytologically confirmed colorectal cancer
Measurable disease
Refractory* to irinotecan, evidenced by clinical documentation
Must have received prior irinotecan according to 1 of the following schedules:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following arterial thromboembolic events within the past 6 months:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior anticancer murine or chimeric monoclonal antibody therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic heparin
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90033 | |
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
New York Weill Cornell Cancer Center at Cornell University | |
New York, New York, United States, 10021 | |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
New York, New York, United States, 10016 | |
United States, Pennsylvania | |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, Texas | |
MD Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Leonard B. Saltz, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000350086, MSKCC-03135, NCI-6444 |
Study First Received: | February 10, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00077298 History of Changes |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Cetuximab Irinotecan Colonic Diseases Rectal Neoplasm Bevacizumab Intestinal Diseases Angiogenesis Inhibitors |
Rectal Diseases Camptothecin Recurrence Intestinal Neoplasms Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Irinotecan Colonic Diseases Physiological Effects of Drugs Bevacizumab Rectal Diseases Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Digestive System Neoplasms |
Growth Substances Cetuximab Enzyme Inhibitors Intestinal Diseases Angiogenesis Inhibitors Camptothecin Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |