Colorectal Cancer
Conditions
Keywords
stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer
Brief 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.
Interventions
DRUGIrinotecan 70 mg/m2
Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29
DRUGIrinotecan 240 mg/m2
Irinotecan i.v. 240 mg/m2 day 1 and day 22
Sponsors
Swiss Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced or metastatic colorectal cancer * Unresectable disease * At least 1 bidimensionally measurable lesion * At least 2 cm in perpendicular diameters * No evidence of CNS metastases PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * 0-1 Life expectancy: * At least 3 months Hematopoietic: * WBC at least 3,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.25 times ULN Cardiovascular: * No clinically significant cardiac disease * No congestive heart failure * No New York Heart Association class III or IV heart disease * No symptomatic coronary artery disease * No uncontrolled cardiac arrhythmia * No myocardial infarction within the past year Gastrointestinal: * No evidence of dysphagia * No malabsorption or intestinal obstruction that would affect absorption or excretion of study drugs * No chronic diarrhea Other: * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer * No psychiatric disability that would preclude study compliance * No other significant medical condition * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for advanced or metastatic disease Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * At least 4 weeks since prior major surgery to the gastrointestinal tract Other: * No concurrent therapy for history of seizures or CNS disorder
Countries
Switzerland
Outcome results
None listed