Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00030797|
Recruitment Status : Completed
First Posted : June 25, 2003
Last Update Posted : May 15, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Irinotecan 70 mg/m2 Drug: Irinotecan 240 mg/m2||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||May 2002|
|Actual Study Completion Date :||December 2003|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030797
|Bern, Switzerland, CH-3010|
|Study Chair:||Markus M. Borner, MD||University Hospital Inselspital, Berne|