combination chemotherapy in treating patients with advanced or metastatic colorectal cancer

Conditions: Colorectal Cancer

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.

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.

Eligibility 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

Keywords: stage iii colon cancer stage iv colon cancer stage iii rectal cancer stage iv rectal cancer