Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Sponsor
Herbert Hurwitz, MD
Study ID
NCT00416494
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    10 mg/kg intravenously over 30-90 minutes on day 1
  • oxaliplatin — DRUG
    85 mg/m2 intravenously over 2 hours on day 1.
  • Capecitabine — DRUG
    Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
  • Capecitabine — DRUG
    Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort

Study Details

RATIONALE: Drugs used in chemotherapy, such as capecitabine, 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 bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab works in treating patients with metastatic or recurrent colorectal cancer.

Key Dates

First listed
Dec 28, 2006
Start date
Sep 30, 2003
Status verified
Aug 2014
Primary completion
Jan 31, 2008
Completion
Aug 31, 2014

Study Design

Enrollment
50 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Initial Cohort
  • Experimental: Second cohort

Primary Outcome Measure

Response Rate (Percentage of Participants With Partial or Complete Response) [ Time Frame: After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months. ]

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