A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy

Roche

Status and phase: Completed; Phase 3

Conditions: Renal Cell Cancer

Treatments: Drug: Placebo; Drug: Bevacizumab [Avastin]; Drug: Interferon alfa 2a [Roferon]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00738530

2004-000282-35 (EudraCT Number)

BO17705

Details and patient eligibility

About

This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (>)500 individuals.

Enrollment: 649 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• metastatic renal cell cancer (clear cell type);
• nephrectomy;
• absence of proteinuria.

Exclusion criteria

• prior systemic treatment for metastatic renal cell cancer;
• major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start;
• presence of brain metastases or spinal cord compression;
• ongoing need for full dose anticoagulants;
• uncontrolled hypertension;
• clinically significant cardiovascular disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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649 participants in 2 patient groups, including a placebo group

Bevacizumab + IFN-Alfa-2A

Experimental group

Description:

Bevacizumab infusions will be administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) will be administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity.

Treatment:

Drug: Interferon alfa 2a [Roferon]

Drug: Bevacizumab [Avastin]

Placebo + IFN-Alfa-2A

Placebo Comparator group

Description:

Placebo matched with Bevacizumab infusions will be administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A will be administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.

Treatment:

Drug: Interferon alfa 2a [Roferon]

Drug: Placebo