An Observational Study of Avastin (Bevacizumab) in Combination With Interferon Alpha-2a as First-Line Treatment in Patients With Advanced and/or Metastatic Renal Cell Carcinoma
Completed
- Conditions
- Renal Cell Cancer
- Registration Number
- NCT01351571
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with interferon alpha-2a as first-line treatment in patients with advanced and/or metastatic renal cell carcinoma. Data will be collected from each patient as per routine clinical practice of the Investigator (maximum of 52 weeks, until disease progression /unacceptable toxicity or withdrawal of consent) and/or based on the local label.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Advanced and/or metastatic renal cell carcinoma
- Receiving first-line treatment with Avastin and interferon alpha-2a according to standard of care and current local label
- At least one measurable and non-measurable lesion according to RECIST criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow, renal and liver function
Exclusion Criteria
- Contraindications to Avastin and/or interferon alpha-2a as per local label
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Incidence of adverse events approximately 4 years
- Secondary Outcome Measures
Name Time Method Overall survival approximately 4 years Overall response rate: complete response or partial response according to RECIST criteria approximately 4 years Progression-free survival: time from first drug administration to documented disease progression or death of any cause approximately 4 years