A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer
- Determine the efficacy of sorafenib, in terms of response rate (confirmed and
unconfirmed, complete and partial), in patients with platinum-refractory or
platinum-sensitive small cell lung cancer.
- Determine the qualitative and quantitative toxic effects of this drug in these
- Determine the overall survival of patients treated with this drug.
- 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. [Analysis is ongoing and will be reported separately.]
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.
PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per stratum) will be accrued for this
study within approximately 7-13 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST)
Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.
8 weeks to 2 years
Barbara J. Gitlitz, MD
USC/Norris Comprehensive Cancer Center
United States: Food and Drug Administration