PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma
NCT ID: NCT00053885
Last Updated: 2016-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2003-07-31
2006-06-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of PTK787/ZK 222584 in treating patients with unresectable malignant mesothelioma.
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Detailed Description
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* Determine the efficacy of PTK787/ZK 222584, in terms of 3-month progression-free survival, in patients with malignant mesothelioma.
* Determine the response rate in patients treated with this drug.
* Determine the toxicity of this drug in these patients.
* Determine the overall and failure-free survival of patients treated with this drug.
* Correlate pretreatment circulating serum levels of vascular endothelial growth factor (VEGF), platelet-derived growth factor, and VEGF mRNA isoforms with response in patients treated with this drug.
OUTLINE: This is a multicenter study.
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
PTK787/ZK 222584
oral
Interventions
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PTK787/ZK 222584
oral
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Thierry Jahan, MD
Role: STUDY_CHAIR
University of California, San Francisco
Locations
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Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States
Naval Medical Center - San Diego
San Diego, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Memorial Regional Cancer Center at Memorial Regional Hospital
Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
West Suburban Center for Cancer Care
River Forest, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Baptist Hospital East - Louisville
Louisville, Kentucky, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at the Cooper University Hospital
Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
NorthEast Oncology Associates - Concord
Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cape Fear Valley Health System
Fayetteville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States
Comprehensive Cancer Center at Moore Regional Hospital
Pinehurst, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States
University of Tennessee Cancer Institute at Methodist Central Hospital
Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke, Virginia, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Countries
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References
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Jahan TM, Gu L, Wang X, et al.: Vatalanib (V) for patients with previously untreated advanced malignant mesothelioma (MM): A phase II study by the Cancer and Leukemia Group B (CALGB 30107). [Abstract] J Clin Oncol 24 (Suppl 18): A-7081, 2006.
Jahan T, Gu L, Kratzke R, Dudek A, Otterson GA, Wang X, Green M, Vokes EE, Kindler HL. Vatalanib in malignant mesothelioma: a phase II trial by the Cancer and Leukemia Group B (CALGB 30107). Lung Cancer. 2012 Jun;76(3):393-6. doi: 10.1016/j.lungcan.2011.11.014. Epub 2011 Dec 22.
Other Identifiers
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CALGB-30107
Identifier Type: -
Identifier Source: secondary_id
CDR0000269537
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-30107
Identifier Type: -
Identifier Source: org_study_id
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