NCT00030797

Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer

A Randomized Phase II Trial Of Capecitabine And Different Schedules Of Irinotecan As First Line Treatment For Advanced Or Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan 70 mg/m2	Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29
DRUG	Irinotecan 240 mg/m2	Irinotecan i.v. 240 mg/m2 day 1 and day 22

Timeline

• Start date: 2001-02-01
• Primary completion: 2002-05-01
• Completion: 2003-12-01
• First posted: 2003-06-25
• Last updated: 2012-05-15

Locations

1 site across 1 country: Switzerland