A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

Sponsor
Hoffmann-La Roche
Study ID
NCT00796757
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
    10mg/kg iv infusion every 2 weeks
  • interferon alfa-2a — DRUG
    3 MIU sc t.i.w.

Study Details

This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Key Dates

First listed
Nov 24, 2008
Start date
Dec 31, 2008
Status verified
May 2015
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months [ Time Frame: 12 and 24 months ]

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