Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer
- Conditions
- Liver Cancer
- Registration Number
- NCT00012324
- Lead Sponsor
- Eximias Pharmaceutical
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for liver cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different chemotherapy regimens in treating patients who have recurrent or unresectable liver cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Time to progression Time to treatment failure Survival probabilities at 3, 6, 9, and 12 months Safety Response rate (complete response, partial response, stable disease) Response to treatment in patients with and without prior therapy
Trial Locations
- Locations (42)
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Oncology-Hematology Group of South Florida, P.A.
🇺🇸Miami, Florida, United States
University of Illinois at Chicago Cancer Center
🇺🇸Chicago, Illinois, United States
California Hematology/Oncology Medical Group
🇺🇸Torrance, California, United States
Fundacion de Investagacion De Diego
🇵🇷Santurce, Puerto Rico
California Pacific Medical Center - Pacific Campus
🇺🇸San Francisco, California, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Olive View - UCLA Medical Center Foundation
🇺🇸Sylmar, California, United States
Ocala Research Institute, Incorporated
🇺🇸Ocala, Florida, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
🇺🇸Baltimore, Maryland, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Cancer Centers of the Carolinas - Eastside
🇺🇸Greenville, South Carolina, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Scripps Cancer Center at Scripps Clinic
🇺🇸La Jolla, California, United States
Florida Cancer Institute - Bayonet Point
🇺🇸Hudson, Florida, United States
Arizona Clinical Research Center, Incorporated
🇺🇸Tucson, Arizona, United States
David and Donna Long Center for Cancer Treatment at Sharp Grossmont Hospital
🇺🇸La Mesa, California, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Tower Cancer Research Foundation
🇺🇸Beverly Hills, California, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Helen F. Graham Cancer Center
🇺🇸Newark, Delaware, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Louisiana Oncology Associates - Lafayette
🇺🇸Lafayette, Louisiana, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Saint Louis University Cancer Center
🇺🇸Saint Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
🇨🇦Ottawa, Ontario, Canada
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States