A Phase II Study of PTK787/ZK222584 (NSC#719335) in Patients With Unresectable Malignant Mesothelioma
OBJECTIVES:
- 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.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 9-13 months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Thierry Jahan, MD
Study Chair
University of California, San Francisco
United States: Food and Drug Administration
CDR0000269537
NCT00053885
July 2003
June 2006
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Martha Jefferson Hospital | Charlottesville, Virginia 22901 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Cancer Institute of New Jersey at the Cooper University Hospital | Camden, New Jersey 08103-1489 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Naval Medical Center - San Diego | San Diego, California 92134-3202 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
Baptist Hospital East - Louisville | Louisville, Kentucky 40207 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Broward General Medical Center | Fort Lauderdale, Florida 33316 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Northeast Alabama Regional Medical Center | Anniston, Alabama 36207 |
Veterans Affairs Medical Center - San Diego | San Diego, California 92161 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Veterans Affairs Medical Center - Washington, DC | Washington, District of Columbia 20422 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
West Suburban Center for Cancer Care | River Forest, Illinois 60305 |
Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne, Indiana 46885-5099 |
Veterans Affairs Medical Center - Las Vegas | Las Vegas, Nevada 89106 |
Elmhurst Hospital Center | Elmhurst, New York 11373 |
Queens Cancer Center of Queens Hospital | Jamaica, New York 11432 |
Veterans Affairs Medical Center - Asheville | Asheville, North Carolina 28805 |
Cape Fear Valley Health System | Fayetteville, North Carolina 28302-2000 |
Lifespan: The Miriam Hospital | Providence, Rhode Island 02906 |
Veterans Affairs Medical Center - Dallas | Dallas, Texas 75216 |
Virginia Oncology Associates - Norfolk | Norfolk, Virginia 23502 |
St. Mary's Medical Center | Huntington, West Virginia 25701 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
Mount Sinai Medical Center | New York, New York 10029 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
Lombardi Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
New Hampshire Oncology-Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
NorthEast Oncology Associates - Concord | Concord, North Carolina 28025 |
University of Tennessee Cancer Institute at Methodist Central Hospital | Memphis, Tennessee 38104 |
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke | Roanoke, Virginia 24014 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Lenoir Memorial Cancer Center | Kinston, North Carolina 28503-1678 |
Comprehensive Cancer Center at Moore Regional Hospital | Pinehurst, North Carolina 28374 |
Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390-9063 |
Memorial Regional Cancer Center at Memorial Regional Hospital | Hollywood, Florida 33021 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |