A Phase III Randomized Controlled Study Comparing the Survival of Patients With Unresectable Hepatocellular Carcinoma (HCC) Treated With THYMITAQ to Patients Treated With Doxorubicin
- 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
- 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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Gregory R. Suplick
United States: Federal Government
|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|