A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum

Sponsor
Hoffmann-La Roche
Study ID
NCT02582970
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • 5-Fluorouracil — DRUG
    Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.
  • Bevacizumab — DRUG
    Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.
  • Irinotecan — DRUG
    Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.
  • Oxaliplatin — DRUG
    Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.

Study Details

This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.

Key Dates

Start date
May 31, 2005
Status verified
Jan 2017
Primary completion
Oct 31, 2007
Completion
Apr 30, 2008

Study Design

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

Arms

  • Experimental: Bevacizumab + Chemotherapy
    Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.

Primary Outcome Measure

Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 3 years ]

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