Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer
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
Sites / Locations
- Inselspital, Bern
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Arm A
Arm B
Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;
Irinotecan i.v. 240 mg/m2 day 1 and day 22; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;