Safety and Efficacy Study Using Bevacizumab, Capecitabine and Oxaliplatin for Colorectal Cancer

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT00177307
Phase
PHASE2
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
  • Capecitabine — DRUG
    Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
  • Oxaliplatin — DRUG
    Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine

Study Details

This is a Phase II study of the drug combination of Oxaliplatin, Avastin and capecitabine. This is an open-label study.

Key Dates

First listed
Sep 15, 2005
Start date
Jan 31, 2005
Status verified
Jun 2016
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

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

Arms

  • Experimental: Oxaliplatin, Capecitabine, and Bevacizumab

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 27 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-

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By research site
University of Pittsburgh Medical Center· Pittsburgh, PA

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