Leucovorin, Fluorouracil, Cetuximab, and Oxaliplatin in Treating Patients With Stage IV Colorectal Cancer and Liver Metastases That Cannot Be Removed by Surgery
|ClinicalTrials.gov Identifier: NCT00544349|
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : May 17, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic Cancer||Biological: cetuximab Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2006|
|Primary Completion Date :||May 2011|
- Efficacy: objective tumor response rate (RECIST criteria)
- Toxicity as assessed by NCI CTCAE v3.0
- Duration of response
- Duration and rate of tumor control
- Secondary resectability of hepatic metastases
- Progression-free survival
- Overall survival
- Tumor progression rate
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544349
|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|
|OverallOfficial:||David Malka, MD, PhD||Gustave Roussy, Cancer Campus, Grand Paris|