A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.

Phase 2

Completed

• Conditions: Renal Cell Cancer
• Interventions: Drug: bevacizumab [Avastin]; Drug: Interferon alfa-2a; Drug: Vinblastine

• Registration Number: NCT00520403
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-23
• Study First Submitted QC: 2007-08-23
• Study First Posted: 2007-08-24
• Study Start: 2007-09
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2014-08-14
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-09
• Last Update Submitted: 2014-10-09
• Results First Posted: 2014-10-13
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• adult patients, >=18 years of age;
• metastatic renal cell cancer of predominantly clear cell type;
• >=1 measurable lesion.

Exclusion Criteria

• prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for metastatic renal cell cancer;
• ongoing or recent need for full therapeutic dose of anticoagulants or chronic daily treatment with aspirin (>325mg/day);
• clinically significant cardiovascular disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	bevacizumab [Avastin]	-
1	Interferon alfa-2a	-
1	Vinblastine	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Objective Response (OR)	Baseline and Cycles 3, 6, 9, 13, and 17	Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST.
Overall Survival (OS)	Baseline, Day 1 of every cycle to disease progression or death (up to Week 102)	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.