Phase 2
N=43
Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma
Malignant Mesothelioma
Bottom Line
View on ClinicalTrials.gov: NCT00509041 ↗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
| Outcome | Result | p-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
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.