Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dasatinib

Criteria

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