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| Sponsor: | North Central Cancer Treatment Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Southwest Oncology Group Eastern Cooperative Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005036 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for colorectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with that of combination chemotherapy in treating patients who have advanced colorectal cancer that has not responded to previous treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: FOLFOX regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients With Advanced Colorectal Carcinoma Previously Treated With 5-FU |
| Study Start Date: | November 1999 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (ECOG 0-1 vs 2), primary indicator lesion (hepatic vs pulmonary vs other), age (less than 65 vs at least 65 years), alkaline phosphatase (less than 2 vs at least 2 times ULN), fluorouracil failure (adjuvant vs metastatic), and membership (intergroup vs expanded participation project).
Patients are randomized to one of two treatment arms:
Patients who experience progression or toxicity on the initial regimen may crossover to the other regimen. At least 3 weeks must elapse between regimens.
Quality of life is assessed at baseline, prior to each chemotherapy course, at crossover, and at the end of the study.
Patients are followed every 6 months for 3 years or until death.
PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Progressive disease following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Show 127 Study Locations| Study Chair: | Henry C. Pitot, MD | Mayo Clinic |
| Study Chair: | Philip A. Philip, MD, PhD, FRCP | Barbara Ann Karmanos Cancer Institute |
| Study Chair: | Edith P. Mitchell, MD, FACP | Kimmel Cancer Center (KCC) |
More Information
| Study ID Numbers: | CDR0000067623, NCCTG-N9841, ECOG-N9841, SWOG-N9841 |
| Study First Received: | April 6, 2000 |
| Last Updated: | October 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005036 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III colon cancer stage IV colon cancer stage III rectal cancer stage IV rectal cancer |
recurrent colon cancer recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Irinotecan Physiological Effects of Drugs Leucovorin Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses |
Micronutrients Vitamin B Complex Digestive System Neoplasms Growth Substances Enzyme Inhibitors Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Camptothecin Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic |