Phase II Studies in Patients With Metastatic Colorectal Carcinoma Previously Treated With Oxaliplatin (OXAL) or a Combination of Irinotecan (CPT-11) and Oxal
- Determine the tumor response rate in patients receiving irinotecan or fluorouracil and
leucovorin calcium for metastatic colorectal cancer previously treated with oxaliplatin
with or without irinotecan.
- Determine the time to tumor progression, time to treatment failure, and overall
survival of patients treated with these regimens.
- Determine the toxic effects of these regimens in these patients.
- Evaluate the quality of life of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (oxaliplatin-based therapy vs irinotecan and oxaliplatin combination therapy).
Patients are assigned to one of two treatment groups.
- Group I (prior oxaliplatin-based chemotherapy): Patients receive irinotecan IV over 90
minutes on day 1. Treatment repeats every 3 weeks.
- Group II (prior irinotecan and oxaliplatin combination chemotherapy): Patients receive
leucovorin calcium IV over 2 hours and fluorouracil IV continuously on days 1 and 2.
Treatment repeats every 2 weeks.
- Both groups: Treatment continues in the absence of disease progression or unacceptable
toxicity. Patients with a confirmed complete response for 2 consecutive courses may
discontinue treatment at investigator's discretion.
Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and
then after the last course of treatment.
Patients are followed every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 40-96 patients (20-48 per arm) will be accrued for this study
within 1-2 years.
Allocation: Non-Randomized, Primary Purpose: Treatment
Henry C. Pitot, MD
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Ann Arbor Regional||Ann Arbor, Michigan 48106|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Scottsdale Oncology Program||Scottsdale, Arizona 85259-5404|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|Siouxland Hematology-Oncology||Sioux City, Iowa 51101-1733|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|Mayo Clinic||Jacksonville, Florida 32224|