Irinotecan in Treating Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed technically resectable metastatic colorectal cancer that is high risk for relapse Must meet one of the following criteria: Metastatic colorectal cancer confined to liver plus portal lymph nodes Recurrent metastatic colorectal cancer confined to liver after first hepatic resection Metastatic colorectal cancer confined to lung plus liver Metastatic colorectal cancer confined to liver with MSKCC risk factor score greater than 4 Metastatic colorectal cancer confined to lung, with either greater than 1 nodule and/or less than 3 years disease free survival Metastatic colorectal cancer confined to ovary Metastatic colorectal cancer confined to a single intraabdominal lymph node Must have failed fluorouracil-based chemotherapy for metastatic disease, received fluorouracil-based chemotherapy in adjuvant setting, have tumor with measured thymidylate synthase level greater than 4.0, or have lung metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No myocardial infarction in the last 6 months Other: No other prior malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No active or uncontrolled infection No psychiatric or other disorders No other concurrent disease that would preclude entry into this study Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior irinotecan or other camptothecins Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Sites / Locations
- Memorial Sloan-Kettering Cancer Center