Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Study ID
NCT00556413
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • cetuximab — BIOLOGICAL
  • fluorouracil — DRUG
  • irinotecan hydrochloride — DRUG
  • leucovorin calcium — DRUG
  • oxaliplatin — DRUG

Study Details

RATIONALE: 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. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with metastatic colorectal cancer.

Key Dates

Start date
Sep 30, 2005
Status verified
Feb 2026
Primary completion
May 31, 2011
Completion
Nov 17, 2011

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ERBIRINOX
    5FU + Irinotecan + Oxaliplatine + Cetuximab

Primary Outcome Measure

Complete response rate [ Time Frame: 6 months ]

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