PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma
Malignant Mesothelioma
About this trial
This is an interventional treatment trial for Malignant Mesothelioma focused on measuring advanced malignant mesothelioma, epithelial mesothelioma, recurrent malignant mesothelioma, sarcomatous mesothelioma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant mesothelioma of 1 of the following types: Epithelial Sarcomatoid Mixed Not amenable to radiotherapy or curative surgery Any site of origin including, but not limited to, the following: Pleura Peritoneum Pericardium Tunica vaginalis At least one unidimensionally measurable lesion outside of prior irradiation port At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan The following are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions No known brain metastases PATIENT CHARACTERISTICS: Age Over 18 Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 2.5 times ULN Renal Creatinine no greater than 1.5 times ULN Negative for proteinuria by dipstick OR Urinary protein no greater than 500 mg and creatinine clearance at least 50 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-barrier contraception No currently active second malignancy except non-melanoma skin cancers (unless therapy is completed and risk of relapse is less than 30%) No other concurrent uncontrolled illness No ongoing active infections No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy No prior signal transduction inhibitor therapy No prior angiogenesis inhibitor therapy Chemotherapy No prior cytotoxic chemotherapy for this malignancy No concurrent chemotherapeutic agents Prior intrapleural cytotoxic or sclerosing therapy (including bleomycin) allowed Endocrine therapy No concurrent hormonal therapy except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes) Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy Surgery See Disease Characteristics At least 2 weeks since prior major surgery Other At least 30 days since prior investigational agents At least 7 days since prior grapefruit or grapefruit juice At least 7 days since prior CYP3A4 inducers No prior PTK787/ZK 222584 No prior tyrosine kinase inhibitor therapy No other concurrent investigational agents No concurrent isoenzyme inducers or inhibitors of p450 No concurrent warfarin or similar oral anticoagulants Heparin allowed No concurrent grapefruit or grapefruit juice No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- Northeast Alabama Regional Medical Center
- Veterans Affairs Medical Center - Birmingham
- Rebecca and John Moores UCSD Cancer Center
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
- Naval Medical Center - San Diego
- Veterans Affairs Medical Center - San Diego
- UCSF Comprehensive Cancer Center
- Veterans Affairs Medical Center - San Francisco
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center at Georgetown University Medical Center
- Walter Reed Army Medical Center
- Veterans Affairs Medical Center - Washington, DC
- Broward General Medical Center
- Memorial Regional Cancer Center at Memorial Regional Hospital
- CCOP - Mount Sinai Medical Center
- Florida Hospital Cancer Institute
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- CCOP - Illinois Oncology Research Association
- West Suburban Center for Cancer Care
- Fort Wayne Medical Oncology and Hematology, Incorporated
- CCOP - Northern Indiana CR Consortium
- Holden Comprehensive Cancer Center at University of Iowa
- Baptist Hospital East - Louisville
- Greenebaum Cancer Center at University of Maryland Medical Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- UMASS Memorial Cancer Center - University Campus
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- CCOP - Kansas City
- Siteman Cancer Center at Barnes-Jewish Hospital
- Missouri Baptist Cancer Center
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - Las Vegas
- New Hampshire Oncology-Hematology, PA - Hooksett
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Cancer Institute of New Jersey at the Cooper University Hospital
- Veterans Affairs Medical Center - Buffalo
- Roswell Park Cancer Institute
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Elmhurst Hospital Center
- Queens Cancer Center of Queens Hospital
- CCOP - North Shore University Hospital
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Weill Cornell Cancer Center at Cornell University
- Mount Sinai Medical Center
- SUNY Upstate Medical University Hospital
- Veterans Affairs Medical Center - Syracuse
- Veterans Affairs Medical Center - Asheville
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- NorthEast Oncology Associates - Concord
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- Cape Fear Valley Health System
- CCOP - Southeast Cancer Control Consortium
- Lenoir Memorial Cancer Center
- Comprehensive Cancer Center at Moore Regional Hospital
- Zimmer Cancer Center at New Hanover Regional Medical Center
- Comprehensive Cancer Center at Wake Forest University
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
- Oklahoma University Medical Center
- Western Pennsylvania Hospital
- Lifespan: The Miriam Hospital
- University of Tennessee Cancer Institute at Methodist Central Hospital
- Veterans Affairs Medical Center - Memphis
- Veterans Affairs Medical Center - Dallas
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Vermont Cancer Center at University of Vermont
- Martha Jefferson Hospital
- Virginia Oncology Associates - Norfolk
- MBCCOP - Massey Cancer Center
- Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
- St. Mary's Medical Center
Arms of the Study
Arm 1
Experimental
PTK787/ZK 222584
Patients receive oral PTK787/ZK 222584 daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.