Phase II Trial of Sorafenib in Conjunction With Chemotherapy and as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer
OBJECTIVES:
- 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
etoposide.
- 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
progression-free survival
1-year
No
Afshin Dowlati, MD
Principal Investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Food and Drug Administration
CASE8507
NCT00726986
July 2008
July 2012
Name | Location |
---|---|
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 |