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CompletedPhase 2NCT00509041
Official study title

Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studieddasatinib

The study team can explain what participation involves.

Who it may be forMesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 11, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?37 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Mesothelioma→
Study topics
After prior treatment→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

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.

View original record ↗