Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver

• Status: Completed
• Trial end date: 2003-04-04
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of liver perfusion using oxaliplatin plus leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer that has spread to the liver.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Calcium; Calcium, Dietary; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS: Histologically proven colorectal cancer metastatic to the liver Unresectable disease Less than 50% invasion of the liver Measurable disease No prior irradiation Largest diameter at least 20 mm No detectable extrahepatic disease

PATIENT CHARACTERISTICS: Age: Under 75 Performance status: WHO 0-2 Life expectancy: Greater than 2 months Hematopoietic: WBC at least 4,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 35 micromoles/L Renal: Creatinine less than 130 micromoles/L Cardiovascular: No severe cardiac insufficiency Pulmonary: No respiratory disease that would preclude study Other: No other serious illness that would preclude study No psychological illness that would preclude study No peripheral neuropathy No prior malignancy not considered cured Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior intravenous oxaliplatin No more than 1 prior regimen of intravenous chemotherapy for metastatic disease Primary chemotherapy of fluorouracil allowed if stable or progressive disease No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics