Evaluation of ZD1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II
OBJECTIVES:
- Determine the 6-month progression-free survival rate of patients with advanced
transitional cell carcinoma of the urothelium treated with ZD 1839.
- Determine the overall survival and response (confirmed complete and partial response)
in these patients treated with this regimen.
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
- Evaluate the changes in growth factor protein kinase expression before and after
treatment and at the time of disease progression in these patients treated with this
regimen.
OUTLINE: Patients receive oral ZD 1839 once daily. Treatment continues in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate
From date of registration until progression or death from any cause, whichever came first, assessed up to 3 years
No
Daniel P. Petrylak, MD
Study Chair
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
CDR0000068509
NCT00014144
February 2001
December 2007
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Arizona Cancer Center | Tucson, Arizona 85724 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Chao Family Comprehensive Cancer Center | Orange, California 92868 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
University of California Davis Medical Center | Sacramento, California 95817 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Loyola University Medical Center | Maywood, Illinois 60153 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
David Grant Medical Center | Travis Air Force Base, California 94535 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
Tulane University School of Medicine | New Orleans, Louisiana 70112 |
Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Columbia River Program | Portland, Oregon 97213 |
CCOP - Greenville | Greenville, South Carolina 29615 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Swedish Cancer Institute | Seattle, Washington 98104 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
Veterans Affairs Medical Center - West Los Angeles | Los Angeles, California 90073 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
Boston Medical Center | Boston, Massachusetts 02118 |
Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
Providence Hospital - Southfield | Southfield, Michigan 48075-9975 |
Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
Oklahoma Medical Research Foundation | Oklahoma City, Oklahoma 73104 |
Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Texas Tech University Health Science Center | Lubbock, Texas 79415 |
Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix, Arizona 85012 |
Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
Oregon Cancer Center | Portland, Oregon 97201-3098 |
Eastern Virginia Medical School | Norfolk, Virginia 23507 |
Veterans Affairs Medical Center - Dallas | Dallas, Texas 75216 |