Malignant Mesothelioma Clinical Trial
Official title:
A Phase II Study of Dasatinib (NSC #732517) in Patients With Previously Treated Malignant Mesothelioma
Verified date | April 2013 |
Source | Alliance for Clinical Trials in Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | December 2012 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed malignant mesothelioma of any of the following subtypes: - Epithelial - Sarcomatoid - Mixed - Any site of origin of malignant mesothelioma allowed including, but not limited to, any of the following: - Pleura - Peritoneum - Pericardium - Tunica vaginalis - Pathology blocks or slides from a core surgical biopsy must be available - Not amenable to curative surgery - Measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional techniques (CT scan , MRI, or x-ray) or as = 10 mm with spiral CT scan - Patients with pleural rind only disease must have at least one level with one rind measurement = 1.5 cm - Lesions that are considered nonmeasurable include the following: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Lymphangitis cutis/pulmonis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Prior treatment with one and only one systemic chemotherapy regimen, which must have included pemetrexed disodium required - Treatment may have been with pemetrexed disodium alone or in combination with any other agent - No symptomatic pleural effusions, unless the patient undergoes a therapeutic thoracentesis - Patients with pleural effusions who have had a pleurodesis are eligible - No known brain metastases - May be registered on CALGB-150707 companion study PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - Granulocytes = 1,500/µL - Platelet count = 100,000/µL - Total bilirubin = 2 x upper limit of normal (ULN) - AST (SGOT) = 2.5 x ULN - Creatinine clearance = 60 mL/min - INR < 1.5 - PTT < 40 seconds - QTc < 450 msec - Not pregnant or nursing - Fertile patients must use effective contraception - No significant cardiac disease, including any of the following: - New York Heart Association (NYHA) class III-IV congestive heart failure (CHF) - Unstable angina - Myocardial infarction or ventricular tachyarrhythmia within 6 months of study entry - Ejection fraction less than institutional normal (in patients with a history of CHF or currently with NYHA class I or II CHF) - Prolonged QTc > 450 msec (Fridericia correction) - Major conduction abnormality, unless a cardiac pacemaker is present - Hypokalemia or hypomagnesemia that cannot be corrected - No history of significant bleeding disorder unrelated to cancer, including any of the following: - Congenital bleeding disorder (e.g., von Willebrand disease) - Acquired bleeding disorder within the past year (e.g., acquired anti-factor VIII antibodies) - Ongoing or recent (= 3 months) significant GI bleeding or hemoptysis - No requirement for supplemental oxygen (i.e., pulse oximetry < 89% at rest) PRIOR CONCURRENT THERAPY: - At least 4 weeks since prior pemetrexed disodium-containing chemotherapy - At least 4 weeks since prior major surgery - At least 4 weeks since prior radiation therapy - Measurable disease must be outside the radiation port - Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) allowed - Intrapleural cytotoxic chemotherapy will not be considered systemic chemotherapy - At least 7 days since prior and no concurrent antithrombotic or anti-platelet agents, including any of the following: - Aspirin or aspirin-containing combinations - Clopidogrel - Dipyridamole - Tirofiban - Epoprostenol - Eptifibatide - Cilostazol - Abciximab - Ticlopidine - Warfarin - Low-dose warfarin for prophylaxis to prevent catheter thrombosis allowed - Heparin or low molecular weight heparin - Heparin for IV line flush allowed - At least 7 days since prior and no concurrent use of the following drugs: - Itraconazole - Ketoconazole (at doses > 200 mg/day) - Miconazole - Voriconazole - Telithromycin - Primidone - Rifabutin - Rifampin - St. John's wort - Carbamazepine - Oxcarbazepine - Rifapentine - Phenobarbital - Phenytoin - Quinidine - Procainamide - Disopyramide - Amiodarone - Sotalol - Ibutilide - Dofetilide - Erythromycin - Clarithromycin - Chlorpromazine - Haloperidol - Mesoridazine - Thioridazine - Pimozide - Bepridil - Droperidol - Halofantrine - Levomethadyl - Sparfloxacin - No concurrent H2 blockers or proton pump inhibitors - No bisphosphonate therapy during the first 8 weeks of study treatment - No concurrent hormones or other chemotherapeutic agents except for steroids administered for dasatinib-related pleural effusion or hormones administered for non-disease-related conditions (e.g., insulin for diabetes) - No concurrent palliative radiation therapy |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Baltimore | Maryland |
United States | Mountainview Medical | Berlin | Vermont |
United States | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Union Hospital Cancer Program at Union Hospital | Elkton MD | Maryland |
United States | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | Kinston Medical Specialists | Kinston | North Carolina |
United States | Howard Community Hospital | Kokomo | Indiana |
United States | Rebecca and John Moores UCSD Cancer Center | La Jolla | California |
United States | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana |
United States | Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware |
United States | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota |
United States | CCOP - Christiana Care Health Services | Newark | Delaware |
United States | Methodist Estabrook Cancer Center | Omaha | Nebraska |
United States | Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida |
United States | Arch Medical Services, Incorporated at Center for Cancer Care and Research | Saint Louis | Missouri |
United States | Missouri Baptist Cancer Center | Saint Louis | Missouri |
United States | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
United States | Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia |
United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Saint Joseph Regional Medical Center | South Bend | Indiana |
United States | South Bend Clinic | South Bend | Indiana |
United States | Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph | Michigan |
United States | Iredell Memorial Hospital | Statesville | North Carolina |
United States | SUNY Upstate Medical University Hospital | Syracuse | New York |
United States | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey |
United States | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington | District of Columbia |
United States | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Cancer and Leukemia Group B | National Cancer Institute (NCI) |
United States,
Dudek A, Pang H, Kratzke RA, et al.: CALGB 30601: A phase II study of dasatinib (D) in patients (pts) with previously treated malignant mesothelioma (MM). [Abstract] J Clin Oncol 28 (Suppl 15) A-7037, 2010.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 24 Week Progression Free Survival | 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. | 24 weeks | No |
Secondary | Number of Participants With Overall Tumor Response | 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. |
Duration of study until progression (up to 3 years) | No |
Secondary | Overall Survival | 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. | Time from registration to death (up to 3 years) | No |
Secondary | Progression Free Survival | 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. | Time from registration to progression or death (up to 3 years) | Yes |
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