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Phase II Trial of Sorafenib in Conjunction With Chemotherapy and as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving sorafenib together with cisplatin and etoposide works in treating patients with 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Columbia Presbyterian
New York, New York, United States
Lake/University Ireland Cancer Center
Cleveland, Ohio, United States
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
CCF-Fairview Hospital
Cleveland, Ohio, United States
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States
Southwest General Health Center
Cleveland, Ohio, United States
UHHS Westlake Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
UH-Monarch
Mayfield Heights, Ohio, United States
Start Date
July 1, 2008
Primary Completion Date
July 1, 2012
Completion Date
July 1, 2012
Last Updated
November 19, 2014
18
ACTUAL participants
cisplatin
DRUG
etoposide
DRUG
sorafenib tosylate
DRUG
Lead Sponsor
Afshin Dowlati, MD
Collaborators
NCT07336732
NCT06066138
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07190248