S0435: Sorafenib in Treating Patients With Extensive Stage Small Cell Lung Cancer
RATIONALE: 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.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with extensive stage small cell lung cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer|
- Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST) [ Time Frame: 8 weeks to 2 years ] [ Designated as safety issue: No ]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.
- Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug [ Time Frame: Patients were assessed for adverse events after completion of every 28-day cycle. ] [ Designated as safety issue: Yes ]Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
- Overall Survival [ Time Frame: 0 - 2 years ] [ Designated as safety issue: No ]Measured from time of registration to death, or last contact date
|Study Start Date:||July 2005|
|Study Completion Date:||July 2011|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Oral sorafenib 400 mg twice daily for 28 day cycle.
400 mg BID (two 200 mg tablets BID, total daily dose is 800 mg) Oral on Days 1-28. Continuous daily dosing.
Other Name: Bay 54-9085
- 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 patients.
- 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.
|Study Chair:||Barbara J. Gitlitz, MD||University of Southern California|
|Principal Investigator:||Bonnie S. Glisson, MD||M.D. Anderson Cancer Center|