A Phase II Study of Dasatinib (NSC #732517, IND #73969) In Patients With Chemosensitive Relapsed Small Cell Lung Cancer
OBJECTIVES:
Primary
- Determine the efficacy of dasatinib in patients with relapsed small cell lung cancer.
Secondary
- Determine the objective response rate (complete and partial response) in patients
treated with this drug.
- Determine the overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Evaluate surrogate biologic markers (FAK, paxillin, and SRC phosphorylation) in
peripheral mononuclear cells (PBMC) and VEGF and PDGF beta in serum.
OUTLINE: Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every
21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at least every 3 months for 1
year and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
6 Week Progression Free Survival
Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method. Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions.
6 weeks
No
Antonius Miller, MD
Study Chair
Comprehensive Cancer Center Hematology/Oncology Wake Forest University
United States: Food and Drug Administration
NCI-2009-00467
NCT00470054
April 2007
June 2010
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Greenville | Greenville, South Carolina 29615 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
CancerCare of Maine at Eastern Maine Medical Center | Bangor, Maine 04401 |
Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Valley Care Medical Center | Pleasanton, California 94588 |
Kaiser Permanente Medical Office -Vandever Medical Office | San Diego, California 92120 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
Fort Wayne Medical Oncology and Hematology | Fort Wayne, Indiana 46815 |
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center | Grand Island, Nebraska 68803 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
Mountainview Medical | Berlin, Vermont 05602 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Highland General Hospital | Oakland, California 94602 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Randolph Hospital | Asheboro, North Carolina 27203 |
Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro, North Carolina 27401 |
Annie Penn Cancer Center | Reidsville, North Carolina 27320 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
Arch Medical Services, Incorporated at Center for Cancer Care and Research | Saint Louis, Missouri 63141 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Kinston Medical Specialists | Kinston, North Carolina 28501 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
La Grange Memorial Hospital | La Grange, Illinois 60525 |
Veterans Affairs Medical Center - Iowa City | Iowa City, Iowa 52246-2208 |
Center for Cancer Care at OSF Saint Anthony Medical Center | Rockford, Illinois 61108 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
East Bay Radiation Oncology Center | Castro Valley, California 94546 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
Tom K Lee, Incorporated | Oakland, California 94609 |
Bay Area Breast Surgeons, Incorporated | Oakland, California 94609 |
Valley Medical Oncology Consultants - Pleasanton | Pleasanton, California 94588 |
Arroyo Grande Community Hospital | Arroyo Grande, California 93420 |
St. Anthony's Cancer Center | St. Louis, Missouri 63128 |
St. Mary's Regional Cancer Center at St. Mary's Medical Center | Huntington, West Virginia 25702 |
Callahan Cancer Center at Great Plains Regional Medical Center | North Platte, Nebraska 69103 |
Valley Medical Oncology Consultants - Castro Valley | Castro Valley, California 94546 |
Valley Medical Oncology | Fremont, California 94538 |
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville, Virginia 24115 |