NCT00098618

Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

A Phase 2 Study Of BAY 43-9006 In Combination With Interferon Alfa-2b In Metastatic Renal Cell Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth or by blocking blood flow to the tumor. Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer. Sorafenib may help interferon alfa kill more tumor cells by making tumor cells more sensitive to the drug. Giving sorafenib together with interferon alfa may kill more tumor cells. This phase II trial is studying how well giving sorafenib with interferon alfa works in treating patients with locally advanced or metastatic kidney cancer.

Detailed description

PRIMARY OBJECTIVES: I. Determine the feasibility and tolerability of sorafenib and interferon alfa in patients with locally advanced or metastatic renal cell carcinoma. II. Determine the response rate (complete response and partial response) in patients treated with this regimen. SECONDARY OBJECTIVES: I. Determine the progression-free survival and response duration of patients treated with this regimen. II. Correlate changes in laboratory parameters with response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral sorafenib twice daily and interferon alfa subcutaneously three times a week for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for 1 year or until disease progression. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 10 months.

Conditions

• Clear Cell Renal Cell Carcinoma
• Papillary Renal Cell Carcinoma
• Recurrent Renal Cell Cancer
• Stage III Renal Cell Cancer
• Stage IV Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	Given orally
BIOLOGICAL	recombinant interferon alfa	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-10-01
• Primary completion: 2006-01-01
• First posted: 2004-12-08
• Last updated: 2013-07-02

Locations

1 site across 1 country: United States