Radiation Therapy, Irinotecan, and Cetuximab in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Rectal Cancer

Sponsor
Centre Hospitalier Universitaire Vaudois
Study ID
NCT00392470
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • cetuximab — BIOLOGICAL
  • irinotecan hydrochloride — DRUG
  • conventional surgery — PROCEDURE
  • neoadjuvant therapy — PROCEDURE
  • 3-dimensional conformal radiation therapy — RADIATION
  • intensity-modulated radiation therapy — RADIATION

Study Details

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as irinotecan, 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 radiation therapy together with irinotecan and cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with cetuximab and radiation therapy in treating patients who are undergoing surgery for stage III or stage IV rectal cancer.

Key Dates

Start date
Aug 31, 2006
Status verified
Apr 2008

Study Design

Enrollment
20 participants (estimated)
Primary purpose
TREATMENT

Primary Outcome Measure

Radiological (clinical) tumor response before surgery

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