A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy

Sponsor
Hoffmann-La Roche
Study ID
NCT00738530
Phase
PHASE3
Status
Completed

Conditions

  • Renal Cell Cancer

Eligibility Criteria

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

Interventions

  • Bevacizumab [Avastin] — DRUG
    10 mg/kg IV every 2 weeks
  • Interferon alfa 2a [Roferon] — DRUG
    9 MIU SC 3 times/week
  • Placebo — DRUG
    IV every 2 weeks

Study Details

This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (\>)500 individuals.

Key Dates

First listed
Aug 20, 2008
Start date
Jun 30, 2004
Status verified
May 2016
Primary completion
Sep 30, 2008
Completion
Sep 30, 2008

Study Design

Enrollment
649 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab + IFN-Alfa-2A
    Bevacizumab infusions will be administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) will be administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity.
  • Placebo Comparator: Placebo + IFN-Alfa-2A
    Placebo matched with Bevacizumab infusions will be administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A will be administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.

Primary Outcome Measure

Percentage of Participants Who Died [ Time Frame: Baseline up to 4.25 years ]

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