Phase II Trial of Sorafenib in Conjunction With Chemotherapy and as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer
- To evaluate the 1-year progression-free survival of patients with extensive-stage small
cell lung cancer treated with sorafenib tosylate in combination with cisplatin and
- To evaluate the 1-year overall survival and response rate in these patients.
- To evaluate the safety of these drugs in these patients.
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes
on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients also receive oral sorafenib tosylate twice
daily beginning on day 1 of course 1 and continuing for up to 1 year in the absence of
disease progression or unacceptable toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Afshin Dowlati, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Lake/University Ireland Cancer Center||Mentor, Ohio 44060|
|MetroHealth Medical Center||Cleveland, Ohio 44109|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|UH-Monarch||Mayfield Heights, Ohio 44124|
|Southwest General Health Center||Middleburgh Heights, Ohio 44130|
|UHHS Chagrin Highlands Medical Center||Orange Villager, Ohio 44122|
|UHHS Westlake Medical Center||Westlaker, Ohio 44145|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|
|UH-Firelands||Sandusky, Ohio 44870|
|Columbia Presbyterian||New York City, New York 10032|
|CCF-Fairview Hospital||Cleveland, Ohio 44111|