Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma
- Registration Number
- NCT00509041
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* To determine the rate of progression-free survival (PFS) at 24 weeks (or 5.5 months) in patients with malignant mesothelioma treated with dasatinib.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dasatinib dasatinib Use of dasatinib in treatment of pts with previously treated malignant mesothelioma
- Primary Outcome Measures
Name Time Method 24 Week Progression Free Survival 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Overall Tumor Response 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 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 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.
Trial Locations
- Locations (37)
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸St. Joseph, Michigan, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Mountainview Medical
🇺🇸Berlin, Vermont, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Kinston Medical Specialists
🇺🇸Kinston, North Carolina, United States
Iredell Memorial Hospital
🇺🇸Statesville, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Methodist Estabrook Cancer Center
🇺🇸Omaha, Nebraska, United States
Masonic Cancer Center at University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton MD, Maryland, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Arch Medical Services, Incorporated at Center for Cancer Care and Research
🇺🇸Saint Louis, Missouri, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States