A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.

Sponsor
Hoffmann-La Roche
Study ID
NCT00520403
Phase
PHASE2
Status
Completed

Conditions

  • Renal Cell Cancer

Eligibility Criteria

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

Interventions

  • bevacizumab [Avastin] — DRUG
    15mg/kg iv every 3 weeks
  • Interferon alfa-2a — DRUG
    3 MioIU sc escalating to 18 MioIU sc, 3 times weekly
  • Vinblastine — DRUG
    0.1mg/kg iv every 3 weeks

Study Details

This single arm study will assess the efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3 weeks. The anticipated time on study treatment is until tumor progression, and the target sample size is 100-500 individuals.

Key Dates

First listed
Aug 24, 2007
Start date
Sep 30, 2007
Status verified
Oct 2014
Primary completion
Mar 31, 2010
Completion
Mar 31, 2010

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

Percentage of Participants With Disease Progression or Death [ Time Frame: Days 0, 91, 182, 273, 365, 456, and 547 ]

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