Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma
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.
Checked against the public recordLast updated Aug 11, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Drug: dasatinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Rebecca and John Moores UCSD Cancer CenterLa Jolla, California
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware
- CCOP - Christiana Care Health ServicesNewark, Delaware
- Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington D.C., District of Columbia
- Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia
- University of Chicago Cancer Research CenterChicago, Illinois
- Elkhart General HospitalElkhart, Indiana
- Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana
- Howard Community HospitalKokomo, Indiana
- Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 11, 2016. Always confirm current availability with the study team.