A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.
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.
Renal Cell Cancer
Drug: bevacizumab [Avastin]
Drug: Interferon alfa-2a
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Percentage of Participants With Disease Progression or Death [ Time Frame: Days 0, 91, 182, 273, 365, 456, and 547 ] [ Designated as safety issue: No ]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 [ Time Frame: Days 0, 91, 182, 273, 365, 456, and 547 ] [ Designated as safety issue: No ]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
- Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline and Cycles 3, 6, 9, 13, and 17 ] [ Designated as safety issue: No ]Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST.
- Overall Survival (OS) [ Time Frame: Baseline, Day 1 of every cycle to disease progression or death (up to Week 102) ] [ Designated as safety issue: No ]OS was defined as the duration from treatment start to death from any cause. Overall survival was censored at the last contact for surviving participants and missing data points.
|Study Start Date:||September 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Drug: bevacizumab [Avastin]
15mg/kg iv every 3 weeksDrug: Interferon alfa-2a
3 MioIU sc escalating to 18 MioIU sc, 3 times weeklyDrug: Vinblastine
0.1mg/kg iv every 3 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520403
|Berlin, Germany, 10117|
|Berlin, Germany, 10967|
|Bremen, Germany, 28277|
|Dessau, Germany, 06846|
|Erlangen, Germany, 91052|
|Frankfurt, Germany, 60596|
|Halle, Germany, 06097|
|Hannover, Germany, 30449|
|Jena, Germany, 07743|
|Kassel, Germany, 34125|
|Kiel, Germany, 24105|
|Leipzig, Germany, 04103|
|Magdeburg, Germany, 39120|
|Rehling, Germany, 86058|
|Stuttgart, Germany, 70174|
|Weiden, Germany, 92637|
|Study Director:||Clinical Trials||Hoffmann-La Roche|