Chemotherapy With or Without Isolated Hepatic Perfusion With Melphalan in Treating Patients With Colorectal Cancer That Has Spread to the Liver
Colorectal Cancer, Metastatic 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, liver metastases
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic colorectal cancer of the parenchyma of the liver No evidence of extrahepatic disease (limited resectable extrahepatic disease allowed) Unresectable liver metastasis, as defined by the following: More than 3 sites of disease Bilobar disease Tumor abutting major vascular or ductal structures Measurable disease No biopsy-proven cirrhosis or evidence of significant portal hypertension manifested by ascites, esophageal varices, or collateral vessels around organs drained by the portal venous system PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count greater than 100,000/mm^3 Hematocrit greater than 27.0% WBC greater than 3,000/mm^3 Hepatic: Bilirubin less than 2.0 mg/dL PT no greater than 2 seconds over upper limit of normal Elevations in transaminases secondary to metastatic disease allowed No veno-occlusive disease No active chronic hepatitis Hepatitis B or C allowed provided there is no evidence of cirrhosis Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No ischemic cardiac disease No prior congestive heart failure with LVEF less than 40% Pulmonary: No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function test less than 50% of predicted Other: No active infections Not pregnant or nursing Negative pregnancy test Weight greater than 30 kg PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy for disease and recovered Chemotherapy: At least 4 weeks since prior chemotherapy for disease and recovered No prior intrahepatic artery infusion therapy with floxuridine Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy for disease and recovered Surgery: Not specified Other: No concurrent immunosuppressive drugs No concurrent chronic anticoagulants
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support