NCT00006050

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

Chemotherapy Intra-Arterial Hepatic With Oxaliplatin Combined With Leucovorin Calcium and Fluorouracil IV

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 0 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: I. Determine the efficacy and tolerance of oxaliplatin by hepatic perfusion combined with intravenous leucovorin calcium and fluorouracil in patients with liver metastases from colorectal cancer. OUTLINE: Patients receive oxaliplatin by hepatic perfusion over 2 hours on day 1 plus leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. If a good response is achieved after 8 courses of chemotherapy, patients may undergo surgical resection of metastases. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Conditions

• Colorectal Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	FOLFOX regimen
DRUG	fluorouracil
DRUG	isolated perfusion
DRUG	leucovorin calcium
DRUG	oxaliplatin

Timeline

• Start date: 1999-04-04
• Primary completion: 2001-12-31
• Completion: 2003-04-04
• First posted: 2004-02-02
• Last updated: 2021-02-17

Locations

3 sites across 1 country: France