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| Sponsor: | Eximias Pharmaceutical |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00012324 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Drug: doxorubicin hydrochloride Drug: nolatrexed dihydrochloride |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | A Phase III Randomized Controlled Study Comparing the Survival of Patients With Unresectable Hepatocellular Carcinoma (HCC) Treated With THYMITAQ to Patients Treated With Doxorubicin |
| Study Start Date: | September 2000 |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically proven or presumptive diagnosis of hepatocellular carcinoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Arizona Clinical Research Center, Incorporated | |
| Tucson, Arizona, United States, 85715 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| California Hematology/Oncology Medical Group | |
| Torrance, California, United States, 90505 | |
| California Pacific Medical Center - Pacific Campus | |
| San Francisco, California, United States, 94115 | |
| David and Donna Long Center for Cancer Treatment at Sharp Grossmont Hospital | |
| La Mesa, California, United States, 91942 | |
| Olive View - UCLA Medical Center Foundation | |
| Sylmar, California, United States, 91342 | |
| Scripps Cancer Center at Scripps Clinic | |
| La Jolla, California, United States, 92037 | |
| Tower Cancer Research Foundation | |
| Beverly Hills, California, United States, 90211 | |
| Veterans Affairs Medical Center - Long Beach | |
| Long Beach, California, United States, 90822 | |
| United States, Delaware | |
| Helen F. Graham Cancer Center | |
| Newark, Delaware, United States, 19713 | |
| United States, District of Columbia | |
| Lombardi Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Florida Cancer Institute - Bayonet Point | |
| Hudson, Florida, United States, 34667 | |
| Ocala Research Institute, Incorporated | |
| Ocala, Florida, United States, 34480 | |
| Oncology-Hematology Group of South Florida, P.A. | |
| Miami, Florida, United States, 33176 | |
| University of Miami Sylvester Comprehensive Cancer Center | |
| Miami, Florida, United States, 33136 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| University of Illinois at Chicago Cancer Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Louisiana | |
| Louisiana Oncology Associates - Lafayette | |
| Lafayette, Louisiana, United States, 70506 | |
| Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | |
| Baltimore, Maryland, United States, 21215 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Saint Louis University Cancer Center | |
| Saint Louis, Missouri, United States, 63110 | |
| Siteman Cancer Center at Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-7680 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New Mexico | |
| Veterans Affairs Medical Center - Albuquerque | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10467 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44111 | |
| United States, Pennsylvania | |
| Albert Einstein Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas - Eastside | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Texas | |
| Joe Arrington Cancer Research and Treatment Center | |
| Lubbock, Texas, United States, 79410-1894 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| Canada, Manitoba | |
| St. Boniface General Hospital | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, Ontario | |
| Ottawa Hospital Regional Cancer Centre - General Campus | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Puerto Rico | |
| Fundacion de Investagacion De Diego | |
| Santurce, Puerto Rico, 00909 | |
| Study Chair: | Gregory R. Suplick | Eximias Pharmaceutical |
More Information
| Study ID Numbers: | CDR0000068506, ZARIX-ZX101-301, AG-337-301 |
| Study First Received: | March 3, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00012324 History of Changes |
| Health Authority: | United States: Federal Government |
|
localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma |
|
Antimetabolites Liver Diseases Antimetabolites, Antineoplastic Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Carcinoma, Hepatocellular Enzyme Inhibitors Folic Acid Antagonists Antibiotics, Antineoplastic |
Pharmacologic Actions Doxorubicin Carcinoma Nolatrexed Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Adenocarcinoma Neoplasms, Glandular and Epithelial |