Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma

NCT00509041 | Completed Phase 2 Results

• 3 other identifiers: CALGB-30601U10CA031946CDR0000558362
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 37

Brief 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.

Conditions

Malignant Mesothelioma

Keywords

advanced malignant mesothelioma; epithelial mesothelioma; recurrent malignant mesothelioma; sarcomatous mesothelioma

Outcome Measures

Primary Outcomes (1)

• 24 Week Progression Free Survival

  Percentage of participants who were alive and progression free at 24 weeks. The 24 week progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.

  24 weeks

Secondary Outcomes (3)

• Number of Participants With Overall Tumor Response

  Duration of study until progression (up to 3 years)

• Overall Survival

  Time from registration to death (up to 3 years)

• Progression Free Survival

  Time from registration to progression or death (up to 3 years)

Study Arms (1)

Dasatinib

EXPERIMENTAL

Use of dasatinib in treatment of pts with previously treated malignant mesothelioma

Drug: dasatinib

Interventions

dasatinib DRUG

50 mg PO bid

Dasatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (37)

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, 32803-1273, United States

Location

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46845, United States

Location

Howard Community Hospital

Kokomo, Indiana, 46904, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Saint Joseph Regional Medical Center

South Bend, Indiana, 46617, United States

Location

South Bend Clinic

South Bend, Indiana, 46617, United States

Location

Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

Union Hospital Cancer Program at Union Hospital

Elkton MD, Maryland, 21921, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

Arch Medical Services, Incorporated at Center for Cancer Care and Research

St Louis, Missouri, 63141, United States

Location

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Kinston Medical Specialists

Kinston, North Carolina, 28501, United States

Location

Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210-1240, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

Mountainview Medical

Berlin Corners, Vermont, 05602, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Related Publications (1)

• Dudek A, Pang H, Kratzke RA, et al.: CALGB 30601: A phase II study of dasatinib (D) in patients (pts) with previously treated malignant mesothelioma (MM). [Abstract] J Clin Oncol 28 (Suppl 15) A-7037, 2010.

  RESULT

MeSH Terms

Conditions

Mesothelioma, Malignant; Solitary Fibrous Tumor, Pleural

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Solitary Fibrous Tumors; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Arkadiusz Dudek, MD, PhD
• Organization: University of Minnesota Masonic Cancer Center

dudek002@umn.edu

Study Officials

• Arkadiusz Dudek, MD

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2007
• First Posted: July 31, 2007
• Study Start: August 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: December 1, 2012
• Last Updated: August 11, 2016
• Results First Posted: January 17, 2013

Record last verified: 2016-07

Locations

US (37)