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

Phase 2CompletedNCT00520403

Hoffmann-La Roche25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Cell Cancer

Interventions

bevacizumab [Avastin]DRUG

15mg/kg iv every 3 weeks

Interferon alfa-2aDRUG

3 MioIU sc escalating to 18 MioIU sc, 3 times weekly

VinblastineDRUG

0.1mg/kg iv every 3 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Unnamed facility

Berlin, Germany

Unnamed facility

Berlin, Germany

Unnamed facility

Bremen, Germany

Unnamed facility

Outcomes

Primary Outcomes

Percentage of Participants With Disease Progression or Death

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.

Time frame: Days 0, 91, 182, 273, 365, 456, and 547

PFS - Time to Event

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

Time frame: Days 0, 91, 182, 273, 365, 456, and 547

Secondary Outcomes

Percentage of Participants With Objective Response (OR)

Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST.

Time frame: Baseline and Cycles 3, 6, 9, 13, and 17

Overall Survival (OS)

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.

Time frame: Baseline, Day 1 of every cycle to disease progression or death (up to Week 102)

Data from ClinicalTrials.gov

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