A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy
Renal Cell Cancer
About this trial
This is an interventional treatment trial for Renal Cell Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Bevacizumab + IFN-Alfa-2A
Placebo + IFN-Alfa-2A
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.
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.