Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer With Liver Metastases or Lung Metastases That Are Potentially Removable by Surgery

Sponsor
Centre Hospitalier Universitaire Vaudois
Study ID
NCT00513266
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
  • cetuximab — BIOLOGICAL
  • fluorouracil — DRUG
  • irinotecan hydrochloride — DRUG
  • leucovorin calcium — DRUG
  • oxaliplatin — DRUG
  • laboratory biomarker analysis — OTHER
  • adjuvant therapy — PROCEDURE
  • biopsy — PROCEDURE
  • conventional surgery — PROCEDURE
  • neoadjuvant therapy — PROCEDURE

Study Details

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, 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. Monoclonal antibodies, such as bevacizumab and 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 combination chemotherapy together with monoclonal antibody therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with monoclonal antibody therapy works in treating patients with advanced colorectal cancer with liver metastases or lung metastases that are potentially removable by surgery.

Key Dates

Start date
Jun 30, 2007
Status verified
Jun 2009

Study Design

Enrollment
35 participants (estimated)
Primary purpose
TREATMENT

Primary Outcome Measure

Pathological complete response rate of lesions of less than or equal to 30 mm in size assessed by pathologic examination in resected specimens

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