Colorectal Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells. It is
not yet known which chemotherapy regimen is more effective for metastatic colorectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of intrahepatic
floxuridine, leucovorin, and dexamethasone with that of systemic fluorouracil and leucovorin
in treating patients who have unresectable liver metastases from colorectal cancer.
OBJECTIVES:
- Compare the efficacy, toxicity, and cost of hepatic artery infusion of floxuridine,
leucovorin calcium (CF), and dexamethasone vs IV fluorouracil and IV CF after resection
of primary disease in patients with hepatic metastases secondary to colorectal cancer.
- Compare the quality of life of patients treated with these regimens.
- Measure the level of thymidylate synthase present in liver metastases, and correlate
these levels with objective response and survival in patients treated with these
regimens.
- Assess the p53 mutations, and correlate findings with objective response and survival
in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, percentage of liver involvement on CT scan or MRI (less than 30% vs 30% to under
70%), prior chemotherapy (none vs adjuvant chemotherapy comprising fluorouracil (5-FU) and
leucovorin calcium (CF) or 5-FU, CF, and levamisole (LEV) completed at least 1 year before
study vs adjuvant chemotherapy comprising 5-FU with or without LEV completed at least 6
months before study), and synchronous disease (yes vs no). Patients are randomized to 1 of 2
treatment arms.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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