Extensive Stage Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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