An Open Label, Prospective, Observational, Non-interventional Study of Bevacizumab in Combination With Interferon Alpha-2a for the First-line Treatment of Patients With Advanced and/or Metastatic Renal Cell Carcinoma

Hoffmann-La Roche0 sites5 target enrollmentAugust 2010

ConditionsRenal Cell Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Renal Cell Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 5
Primary Endpoint: Safety: Incidence of adverse events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

August 2011

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Safety: Incidence of adverse events

Time Frame: approximately 4 years

Secondary Outcomes

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)