Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy
OBJECTIVES:
- Compare the duration of survival of patients with stage IV transitional cell carcinoma
of the urothelium treated with cisplatin and gemcitabine with or without paclitaxel.
- Compare the duration of progression-free survival, response rates, and duration of
response in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to participating center, WHO performance status (0 vs 1), and presence of
metastatic disease (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and
cisplatin IV over 1 hour on day 1 or 2. Treatment repeats every 28 days for a maximum
of 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive paclitaxel IV over 1 hour on days 1 and 8 followed by
cisplatin IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8.
Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for at least 3
years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 610 patients (305 per treatment arm) will be accrued for this
study within 3.04 years.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Joaquim Bellmunt, MD, PhD
Study Chair
Vall d'Hebron University Hospital
United States: Federal Government
EORTC-30987
NCT00022191
May 2001
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
Tulane University School of Medicine | New Orleans, Louisiana 70112 |
Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
Harrington Cancer Center | Amarillo, Texas 79106 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | Orange, California 92868 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
Veterans Affairs Medical Center - Charleston | Charleston, South Carolina 29401-5799 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
University of California Davis Cancer Center | Sacramento, California 95817 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
Veterans Affairs Medical Center - Amarillo | Amarillo, Texas 79106 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
St. Louis University Hospital Cancer Center | Saint Louis, Missouri 63110 |
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73126 |
Providence Cancer Institute at Providence Hospital | Southfield, Michigan 48075 |
Southwest Cancer and Research Center at University Medical Center | Lubbock, Texas 79415-3364 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Del Rio, Texas 78840 |