PHASE III STUDY OF HEPATIC ARTERY FLOXURIDINE (FUDR), LEUCOVORIN (LV), AND DEXAMETHASONE (DEX) VERSUS SYSTEMIC 5-FLUOROURACIL (5-FU) AND LEUCOVORIN (LV) AS TREATMENT FOR HEPATIC METASTASES FROM COLORECTAL CANCER

Fecha de inicio: 1 de enero de 1996

DISEASE CHARACTERISTICS: Unresectable liver metastases secondary to colorectal cancer Less than 70% liver involvement on CT scan or MRI Liver biopsy required before study unless 1 of the following conditions are met: Carcinoembryonic antigen greater than 30 5 or more liver metastases visible on CT scan or MRI Greater than 50% to under 70% liver involvement on CT scan or MRI Histologically proven primary colorectal cancer that is resected or appears resectable on CT scan and physical exam Documentation of previously resected primaries must be based on pathologic results of the resected tumor Histological documentation of synchronous disease must be based on 1 of the following: Biopsy of primary colorectal tumor before study Suspicious lesion on barium enema, colonoscopy, or sigmoidoscopy, and a liver biopsy positive for adenocarcinoma consistent with the primary colorectal tumor Measurable disease Clearly defined liver mass measuring at least 2 cm or at least 3 liver masses on CT scan or MRI No evidence of extrahepatic disease on CT scan and physical exam No portal vein occlusion or ascites PATIENT CHARACTERISTICS: Age: 18 and over Hepatic: Bilirubin no greater than 2 times normal Other: No other malignancy within the past 5 years except inactive nonmelanomatous skin cancer, carcinoma in situ of the cervix, or grade 1 bladder cancer Not pregnant or nursing Fertile patients must use effective contraception Chemotherapy: At least 1 year since prior adjuvant chemotherapy comprising fluorouracil (5-FU) and leucovorin calcium (CF) or 5-FU, CF, and levamisole (LEV) At least 6 months since prior adjuvant chemotherapy comprising 5-FU with or without LEV No other prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except for nondisease-related conditions, e.g.: Steroids for adrenal failure Insulin for diabetes Intermittent dexamethasone as an antiemetic Radiotherapy: No prior radiotherapy to the liver