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
- Determine the efficacy of this regimen by the measurement of objective response rate
- 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.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Efficacy: objective tumor response rate (RECIST criteria)
David Malka, MD, PhD
Gustave Roussy, Cancer Campus, Grand Paris
United States: Federal Government