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Phase 2 N=43 Treatment

Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma

Malignant Mesothelioma

Enrolled (actual)
43
Serious AEs
34.9%
Results posted
Jan 2013
Primary outcome: Primary: 24 Week Progression Free Survival — 23 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
dasatinib (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Alliance for Clinical Trials in Oncology
Primary completion
Feb 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
24 Week Progression Free Survival
23
SECONDARY
Number of Participants With Overall Tumor Response
0; 2
SECONDARY
Overall Survival
26.1
SECONDARY
Progression Free Survival
9.1

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.

Eligibility 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 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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00509041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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