Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
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.
PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced or metastatic colorectal cancer.
|Colorectal Cancer||Drug: Irinotecan 70 mg/m2 Drug: Irinotecan 240 mg/m2||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial Of Capecitabine And Different Schedules Of Irinotecan As First Line Treatment For Advanced Or Metastatic Colorectal Cancer|
|Study Start Date:||February 2001|
|Study Completion Date:||December 2003|
|Primary Completion Date:||May 2002 (Final data collection date for primary outcome measure)|
Active Comparator: Arm A
Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;
Drug: Irinotecan 70 mg/m2
Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29
Active Comparator: Arm B
Irinotecan i.v. 240 mg/m2 day 1 and day 22; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;
Drug: Irinotecan 240 mg/m2
Irinotecan i.v. 240 mg/m2 day 1 and day 22
- Compare the efficacy of different schedules of irinotecan in combination with capecitabine as first-line therapy, in terms of objective response rate, in patients with advanced or metastatic colorectal cancer.
- Compare the time to treatment failure, time to progression, and overall survival of patients treated with these regimens.
- Compare the safety profile, in terms of toxicity, of these regimens in these patients.
- Determine the quality of life in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1); disease symptoms, including pain, weight loss, loss of appetite, malaise, and fever of unknown origin (yes vs no); weight loss during the past 6 months (more than 5% vs 5% or less); and disease-free interval (more than 6 months vs 6 months or less). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive irinotecan IV over 1 hour on days 1, 8, 15, 22, and 29 and oral capecitabine twice daily on days 1-14 and 22-35.
- Arm II: Patients receive irinotecan IV over 1 hour on days 1 and 22 and oral capecitabine as in arm I.
Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, and at the first visit after treatment failure.
Patients are followed every 12 weeks for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 28-74 patients (14-37 per treatment arm) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030797
|Bern, Switzerland, CH-3010|
|Study Chair:||Markus M. Borner, MD||University Hospital Inselspital, Berne|