Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00509041|
Recruitment Status : Completed
First Posted : July 31, 2007
Results First Posted : January 17, 2013
Last Update Posted : August 11, 2016
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with previously treated malignant mesothelioma.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma||Drug: dasatinib||Phase 2|
- To determine the rate of progression-free survival (PFS) at 24 weeks (or 5.5 months) in patients with malignant mesothelioma treated with dasatinib.
- To determine the response rate (partial response [PR] and complete response [CR]) in patients with malignant mesothelioma treated with dasatinib.
- To determine the response duration in patients with malignant mesothelioma treated with dasatinib.
- To describe the overall survival (OS) of patients with malignant mesothelioma treated with dasatinib.
- To describe the toxicity profile of dasatinib in patients with malignant mesothelioma.
- To determine whether the amount of expression of EphA2 and PDGFRβ, as measured by immunohistochemistry from tumor specimens, correlates with PFS in patients with malignant mesothelioma.
- To determine whether plasma levels of VEGF and PDGFRβ, serum levels of CSF-1, and soluble mesothelin-related protein correlate with PFS in patients with malignant mesothelioma.
- To determine whether inhibition of Src phosphorylation in PBMC correlates with PFS.
- To assess inhibition of phosphorylation of Src, EphA2, and PDGFRβ in tumor tissue by dasatinib.
OUTLINE: Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection periodically for correlative studies. Tumor tissue samples are analyzed for EphA2 and PDGFRβ expression by immunohistochemistry. Tumor tissue samples may also be analyzed for phosphorylation of Src, EphA2, and PDGFRβ by western blot. Blood samples are analyzed for concentration of VEGF and PDGF by quantitative sandwich enzyme immunoassay technique; mesothelin-related protein level by Mesomark® assay; CSF-1 level by ELISA assay; and phosphorylation of Src by phospho-Src (pTyr418) human ELISA.
After completion of study treatment, patients are followed at least every 2 months for 1 year, then every 4 months for 1 year, then every 6 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Dasatinib (NSC #732517) in Patients With Previously Treated Malignant Mesothelioma|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||December 2012|
Use of dasatinib in treatment of pts with previously treated malignant mesothelioma
50 mg PO bid
- 24 Week Progression Free Survival [ Time Frame: 24 weeks ]Percentage of participants who were alive and progression free at 24 weeks. The 24 week progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
- Number of Participants With Overall Tumor Response [ Time Frame: Duration of study until progression (up to 3 years) ]
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
- Complete Response (CR): disappearance of all target lesions;
- Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
- Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;
- Stable Disease (SD): small changes that do not meet above criteria.
Overall tumor response is the total number of CR and PRs.
- Overall Survival [ Time Frame: Time from registration to death (up to 3 years) ]Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
- Progression Free Survival [ Time Frame: Time from registration to progression or death (up to 3 years) ]Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509041
|United States, California|
|Rebecca and John Moores UCSD Cancer Center|
|La Jolla, California, United States, 92093-0658|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, Delaware|
|Tunnell Cancer Center at Beebe Medical Center|
|Lewes, Delaware, United States, 19958|
|CCOP - Christiana Care Health Services|
|Newark, Delaware, United States, 19713|
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|United States, Florida|
|Florida Hospital Cancer Institute at Florida Hospital Orlando|
|Orlando, Florida, United States, 32803-1273|
|United States, Georgia|
|Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center|
|Savannah, Georgia, United States, 31403-3089|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Indiana|
|Elkhart General Hospital|
|Elkhart, Indiana, United States, 46515|
|Fort Wayne Medical Oncology and Hematology|
|Fort Wayne, Indiana, United States, 46845|
|Howard Community Hospital|
|Kokomo, Indiana, United States, 46904|
|Center for Cancer Therapy at LaPorte Hospital and Health Services|
|La Porte, Indiana, United States, 46350|
|CCOP - Northern Indiana CR Consortium|
|South Bend, Indiana, United States, 46601|
|Memorial Hospital of South Bend|
|South Bend, Indiana, United States, 46601|
|Saint Joseph Regional Medical Center|
|South Bend, Indiana, United States, 46617|
|South Bend Clinic|
|South Bend, Indiana, United States, 46617|
|United States, Maryland|
|Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center|
|Baltimore, Maryland, United States, 21237|
|Union Hospital Cancer Program at Union Hospital|
|Elkton MD, Maryland, United States, 21921|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|Lakeland Regional Cancer Care Center - St. Joseph|
|St. Joseph, Michigan, United States, 49085|
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Missouri|
|Missouri Baptist Cancer Center|
|Saint Louis, Missouri, United States, 63131|
|Arch Medical Services, Incorporated at Center for Cancer Care and Research|
|Saint Louis, Missouri, United States, 63141|
|United States, Nebraska|
|Methodist Estabrook Cancer Center|
|Omaha, Nebraska, United States, 68114|
|United States, New Jersey|
|Cancer Institute of New Jersey at Cooper - Voorhees|
|Voorhees, New Jersey, United States, 08043|
|United States, New York|
|SUNY Upstate Medical University Hospital|
|Syracuse, New York, United States, 13210|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Wayne Memorial Hospital, Incorporated|
|Goldsboro, North Carolina, United States, 27534|
|Kinston Medical Specialists|
|Kinston, North Carolina, United States, 28501|
|Iredell Memorial Hospital|
|Statesville, North Carolina, United States, 28677|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210-1240|
|United States, South Carolina|
|CCOP - Greenville|
|Greenville, South Carolina, United States, 29615|
|United States, Vermont|
|Berlin, Vermont, United States, 05602|
|Fletcher Allen Health Care - University Health Center Campus|
|Burlington, Vermont, United States, 05401|
|United States, Virginia|
|Danville Regional Medical Center|
|Danville, Virginia, United States, 24541|
|Study Chair:||Arkadiusz Dudek, MD||Masonic Cancer Center, University of Minnesota|