An Open-label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Standard Therapy on Progression-free Survival in Patients With Metastatic Renal Cell Cancer.

NCT00520403 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	COMPLETED
Enrolment	25
Start date	2007-09
Completion	2010-03

Conditions

• Renal Cell Cancer

Interventions

• bevacizumab [Avastin]
• Interferon alfa-2a
• Vinblastine

Primary outcomes

• Percentage of Participants With Disease Progression or Death — Days 0, 91, 182, 273, 365, 456, and 547
  Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination.
• PFS - Time to Event — Days 0, 91, 182, 273, 365, 456, and 547
  PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method

Countries

Germany