NCT00544349

Leucovorin, Fluorouracil, Cetuximab, and Oxaliplatin in Treating Patients With Stage IV Colorectal Cancer and Liver Metastases That Cannot Be Removed by Surgery

Phase II Study Evaluating the Effectiveness of the Association of Chemotherapy LV5FU2 Simplified and Cetuximab With Intra-arterial Hepatic Chemotherapy Using Oxaliplatin in Patients With Colorectal Cancer and Nonresectable Hepatic Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) and giving them together with cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving leucovorin together with fluorouracil, cetuximab, and oxaliplatin works in treating patients with stage IV colorectal cancer and liver metastases that cannot be removed by surgery.

Detailed description

OBJECTIVES: Primary * Determine the efficacy of this regimen by the measurement of objective response rate (RECIST criteria). Secondary * Determine the toxicity of this regimen. * Evaluate the duration of tumor response. * Determine the duration and rate of tumor control. * Determine the rate of secondary resectability of hepatic metastases. * Evaluate progression-free survival * Determine rate of progression of the tumor. * Determine overall survival. OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1 hour, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours. Patients also receive oxaliplatin by hepatic arterial infusion over 2 hours. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity.

Conditions

• Colorectal Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	cetuximab
DRUG	fluorouracil
DRUG	leucovorin calcium
DRUG	oxaliplatin

Timeline

• Start date: 2006-10-01
• Primary completion: 2011-05-01
• First posted: 2007-10-16
• Last updated: 2011-05-17

Locations

7 sites across 1 country: France