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

Phase 2

Completed

• Conditions: Colorectal Cancer; Metastatic Cancer

• Registration Number: NCT00544349
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief 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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-10-13
• Study First Submitted QC: 2007-10-13
• Study First Posted: 2007-10-16
• Status Verified: 2009-07
• Primary Completion: 2011-05
• Last Update Submitted: 2011-05-14
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy: objective tumor response rate (RECIST criteria)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Centre Eugene Marquis; 🇫🇷 Rennes, France

Centre de Lutte Contre le Cancer Georges-Francois Leclerc; 🇫🇷 Dijon, France

Centre Regional Francois Baclesse; 🇫🇷 Caen, France

Hopital Saint Andre; 🇫🇷 Bordeaux, France

CHU Pitie-Salpetriere; 🇫🇷 Paris, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Hopital Paul Brousse; 🇫🇷 Villejuif, France