Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver (6655)
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, adenocarcinoma of the colon, adenocarcinoma of the rectum, liver metastases
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic colorectal adenocarcinoma Measurable metastasis to liver at least 1.0 cm Less than 75% of total liver volume Known extrahepatic disease limited to lymph nodes and less than 2 cm No ascites Ineligible for surgery PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 2,000/mm^3 Platelet count at least 90,000/mm^3 No bleeding diathesis not correctable by standard therapy Hepatic: Ineligible if all of the following criteria are concurrently present: High risk of hepatic failure (more than 50% liver involvement by tumor) Bilirubin greater than 2.0 mg/dL SGOT greater than 100 U/L Lactate dehydrogenase greater than 425 U/L No hepatic encephalopathy No portal vein occlusion without hepatopedal collateral flow demonstrated by angiography No portal hypertension with hepatofugal flow Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No evidence of congestive heart failure No severe peripheral vascular disease that would preclude catheterization Other: No severe allergy or intolerance to contrast media, narcotics, sedatives, or atropine No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior adjuvant immunotherapy regimen for colon cancer Chemotherapy: At least 6 months since prior adjuvant chemotherapy and recovered No more than 1 prior adjuvant chemotherapy regimen for colon cancer No prior hepatic arterial infusion chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 1 month since prior radiotherapy No prior hepatic radiotherapy Surgery: At least 1 month since prior surgery Prior surgical resection or ablation of liver metastases allowed Other: No other concurrent therapy
Sites / Locations
- Arizona Cancer Center
- H. Lee Moffitt Cancer Center and Research Institute
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Beth Israel Deaconess Medical Center
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- State University of New York - Upstate Medical University
- University of Pennsylvania Cancer Center
- University of Texas - MD Anderson Cancer Center