A Phase III Randomized Controlled Study Comparing the Survival of Patients With Unresectable Hepatocellular Carcinoma (HCC) Treated With THYMITAQ to Patients Treated With Doxorubicin
OBJECTIVES:
- Compare the overall survival in patients with unresectable or recurrent hepatocellular
carcinoma treated with nolatrexed dihydrochloride vs doxorubicin.
- Compare time to progression, time to treatment failure, and response rates in patients
treated with these regimens.
- Compare the probability of survival at 3, 6, 9, and 12 months in patients treated with
these regimens.
- Compare the safety and clinical benefit of these regimens in these patients.
- Compare the response rates and survival of patients who have received prior therapy or
no prior therapy after treatment with these two regimens.
- Compare the rates of conversion from unresectable to resectable lesions in patients
treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to CLIP score (0-1 vs 2-3) and Karnofsky performance status (60-70% vs 80-100%).
Patients are randomized to one of two treatment arms.
- Arm I: Patients receive nolatrexed dihydrochloride IV continuously on days 1-5.
- Arm II: Patients receive doxorubicin IV on day 1. Treatment continues in both arms
every 3 weeks in the absence of unacceptable toxicity or disease progression.
Patients are followed every 2 months for survival.
PROJECTED ACCRUAL: Approximately 446 patients (223 per treatment arm) will be accrued for
this study within 12 months.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Overall survival
No
Gregory R. Suplick
Study Chair
Eximias Pharmaceutical
United States: Federal Government
ZARIX-ZX101-301
NCT00012324
September 2000
November 2005
Name | Location |
---|---|
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
New York Medical College | Valhalla, New York 10595 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore, Maryland 21215 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Scripps Cancer Center at Scripps Clinic | La Jolla, California 92037 |
Lombardi Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
University of Illinois at Chicago Cancer Center | Chicago, Illinois 60612 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans | New Orleans, Louisiana 70112 |
Cancer Centers of the Carolinas - Eastside | Greenville, South Carolina 29601 |
Arizona Clinical Research Center, Incorporated | Tucson, Arizona 85715 |
Tower Cancer Research Foundation | Beverly Hills, California 90211 |
David and Donna Long Center for Cancer Treatment at Sharp Grossmont Hospital | La Mesa, California 91942 |
California Pacific Medical Center - Pacific Campus | San Francisco, California 94115 |
Olive View - UCLA Medical Center Foundation | Sylmar, California 91342 |
California Hematology/Oncology Medical Group | Torrance, California 90505 |
Helen F. Graham Cancer Center | Newark, Delaware 19713 |
Florida Cancer Institute - Bayonet Point | Hudson, Florida 34667 |
Oncology-Hematology Group of South Florida, P.A. | Miami, Florida 33176 |
Ocala Research Institute, Incorporated | Ocala, Florida 34480 |
Louisiana Oncology Associates - Lafayette | Lafayette, Louisiana 70506 |