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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00012389 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if irinotecan is more effective with or without oxaliplatin in treating metastatic colorectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with or without oxaliplatin in treating patients who have metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: irinotecan hydrochloride Drug: oxaliplatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | A Multicenter, Open-Label, Randomized, Two-Arm Study of Irinotecan (CPT-11) Versus the Combination of Oxaliplatin + Irinotecan (CPT-11) as Second-Line Treatment of Metastatic Colorectal Carcinoma |
| Study Start Date: | December 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs involved (1 vs 2 or more), lactic dehydrogenase (no greater than 1.5 times upper limit of normal (ULN) vs greater than 1.5 times ULN), and prior fluorouracil chemotherapy (adjuvant vs first-line treatment for metastatic disease). Patients are randomized to 1 of 2 treatment arms.
Courses repeat in each arm every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days, every 4 weeks for 3 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 596 patients (298 per arm) will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 154 Study Locations| Study Chair: | Daniel G. Haller, MD | Abramson Cancer Center of the University of Pennsylvania |
More Information
| Study ID Numbers: | CDR0000068524, SANOFI-EFC4585 |
| Study First Received: | March 3, 2001 |
| Last Updated: | November 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00012389 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 Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Irinotecan Enzyme Inhibitors Intestinal Diseases Rectal Diseases Pharmacologic Actions |
Camptothecin Intestinal Neoplasms Neoplasms Oxaliplatin Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |