NCT00101114

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

A Phase II Study of the RAF-Kinase Inhibitor BAY 43-9006 (NSC-724772, IND-69,896) in Combination With Interferon-Alpha 2B in Patients With Advanced Renal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving sorafenib with interferon alfa works in treating patients with metastatic or unresectable kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer. Sorafenib may help interferon alfa work better by making tumor cells more sensitive to the drug

Detailed description

PRIMARY OBJECTIVES: I. To assess response (confirmed complete and partial responses) of patients with advanced renal cell cancer treated with the combination of BAY-43-9006 and interferon alfa-2b. SECONDARY OBJECTIVES: I. To assess the probability of treatment failure at 6 months and the median overall survival of this group of patients. II. To evaluate the quantitative and qualitative toxicities of this regimen. III. To investigate in a preliminary manner the association of tumor response with measures of increased signaling through the Ras-Raf pathway (p-MAPK, p-JNK, p-p38, and p-AKT), with VHL gene status, and whether changes in levels of IL-6 and tumor markers of hypoxia including PAI-1, VEGF, and osteopontin correspond with clinical outcomes. OUTLINE: This is a multicenter study. Patients receive oral sorafenib twice daily on days 1-28 and interferon alfa subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Conditions

• Clear Cell 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 PO
BIOLOGICAL	recombinant interferon alfa-2b	Given SC
OTHER	laboratory biomarker analysis	Optional correlative studies

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-05-01
• First posted: 2005-01-10
• Last updated: 2013-02-28

Locations

1 site across 1 country: United States