Leucovorin, Fluorouracil, Cetuximab, and Oxaliplatin in Treating Patients With Stage IV Colorectal Cancer and Liver Metastases That Cannot Be Removed by Surgery
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.
Drug: leucovorin calcium
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Efficacy: objective tumor response rate (RECIST criteria) [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Duration of response [ Designated as safety issue: No ]
- Duration and rate of tumor control [ Designated as safety issue: No ]
- Secondary resectability of hepatic metastases [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Tumor progression rate [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- Determine the efficacy of this regimen by the measurement of objective response rate (RECIST criteria).
- 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.
|Hopital Saint Andre|
|Bordeaux, France, 33075|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Centre de Lutte Contre le Cancer Georges-Francois Leclerc|
|Dijon, France, 21079|
|Paris, France, 75651|
|Centre Eugene Marquis|
|Rennes, France, 35062|
|Hopital Paul Brousse|
|Villejuif, France, 94804|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Investigator:||David Malka, MD, PhD||Gustave Roussy, Cancer Campus, Grand Paris|