NCT00182689

Sorafenib in Treating Patients With Extensive Stage Small Cell Lung Cancer

A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well sorafenib works in treating patients with extensive stage small cell lung cancer. Sorafenib may stop the growth of small cell lung cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of BAY 43-0006 in previously-treated, platinum-sensitive and platinum-refractory patients with measurable disease and extensive stage small cell lung cancer (E-SCLC) in terms of response rate (confirmed and unconfirmed, complete and partial). SECONDARY OBJECTIVES: I. To assess the qualitative and quantitative toxicities of BAY 43-9006 in this patient population. II. To assess overall survival in this group of patients treated with BAY 43-9006. III. To collect specimens via the Lung Cancer Specimen Repository Protocol (S9925) in order to perform exploratory analyses of the relationship between selected markers and patient outcomes. OUTLINE: This is a multicenter study. Patients are stratified according to platinum sensitivity status (platinum sensitive vs platinum refractory). Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for up to 2 years from study entry.

Conditions

• Extensive Stage Small Cell Lung Cancer
• Recurrent Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	Given orally

Timeline

• Start date: 2005-07-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2005-09-16
• Last updated: 2014-05-21
• Results posted: 2012-09-19

Locations

1 site across 1 country: United States