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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Cell Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

15mg/kg iv every 3 weeks

Interferon alfa-2a

Intervention Type DRUG

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

Vinblastine

Intervention Type DRUG

0.1mg/kg iv every 3 weeks

Interventions

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bevacizumab [Avastin]

15mg/kg iv every 3 weeks

Intervention Type DRUG

Interferon alfa-2a

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

Intervention Type DRUG

Vinblastine

0.1mg/kg iv every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No