Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
- Sponsor
- Institut Cancerologie de l'Ouest
- Study ID
- NCT00559741
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- cetuximab — BIOLOGICAL
- fluorouracil — DRUG
- irinotecan hydrochloride — DRUG
- leucovorin calcium — DRUG
- pharmacological study — OTHER
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, such as irinotecan, fluorouracil, and leucovorin, 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 in treating patients with advanced or metastatic colorectal cancer.
Key Dates
- Start date
- Oct 31, 2005
- Status verified
- May 2011
- Primary completion
- May 31, 2011
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Primary purpose
- TREATMENT
Primary Outcome Measure
Improvement of hematologic and gastrointestinal tolerance to therapy
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