A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

Roche

Status and phase: Completed; Phase 2

Conditions: Renal Cell Cancer

Treatments: Drug: bevacizumab [Avastin]; Drug: interferon alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT00796757

2007-006611-23

MO21609

Details and patient eligibility

About

This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• metastatic RCC with majority (>50%) of conventional clear-cell type;
• prior total nephrectomy for primary RCC;
• at least one measurable or non-measurable lesions;
• ECOG performance score of 0 or 2.

Exclusion criteria

• prior systemic treatment for metastatic RCC;
• current or previously treated but non-stable CNS metastases or spinal cord compression;
• major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment;
• significant cardiovascular disease within 6 months prior to enrollment.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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146 participants in 1 patient group

1

Experimental group

Treatment:

Drug: interferon alfa-2a

Drug: bevacizumab [Avastin]