Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed adenocarcinoma of the colon or rectum
• •Metastatic or recurrent disease that is not amenable to potentially curative treatment
• •Progressive or recurrent disease during or after 1, and only 1, regimen of fluorouracil with or without leucovorin calcium or during or within 6 months after adjuvant chemotherapy with fluorouracil and leucovorin calcium
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •Karnofsky 50-100%
• •Life expectancy:
• •Not specified
• •Hematopoietic:
• •Absolute neutrophil count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hepatic:
• •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• •SGOT/SGPT no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present)
• •Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present)
• •Renal:
• •Creatinine no greater than 1.5 times ULN
• •Cardiovascular:
• •No unstable angina
• •No New York Heart Association class III or IV congestive heart failure
• •No serious cardiac arrhythmia
• •No history of cardiac toxicity from fluorouracil/leucovorin calcium
• •No myocardial infarction within past 6 months
• •Pulmonary:
• •No interstitial pneumonia or extensive and symptomatic fibrosis of the lung
• •Other:
• •No uncontrolled predisposing colonic or small bowel disorder
• •No prior chronic enteropathy, chronic diarrhea, or unresolved bowel obstruction/subobstruction
• •No diabetes
• •No active infection
• •No known current peripheral neuropathy
• •No concurrent active cancer except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
• •No intolerance of appropriate antiemetics
• •No history of anaphylaxis or potential intolerance to atropine sulfate or loperamide
• •Not pregnant or nursing
• •Negative pregnancy test
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •Not specified
• •Chemotherapy:
• •See Disease Characteristics
• •At least 3 weeks since prior chemotherapy
• •No prior irinotecan or oxaliplatin
• •No other prior chemotherapy agents except fluorouracil with or without leucovorin calcium as first-line therapy for metastatic disease or in the adjuvant setting
• •Endocrine therapy:
• •Not specified
• •Radiotherapy:
• •Prior radiotherapy to non-target lesions allowed
• •No prior radiotherapy to target lesions unless disease progression is documented within the radiation port
• •At least 3 weeks since prior radiotherapy
• •Surgery:
• •At least 4 weeks since prior major surgical procedure and recovered
• •Prior surgery for primary tumor or metastasis allowed
• •Other:
• •At least 30 days since prior investigational drug
• •No concurrent investigational agents