Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer
NCT ID: NCT00012324
Last Updated: 2013-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2000-09-30
2005-11-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of two different chemotherapy regimens in treating patients who have recurrent or unresectable liver cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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doxorubicin hydrochloride
nolatrexed dihydrochloride
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically proven or presumptive diagnosis of hepatocellular carcinoma
* Presumptive diagnosis based on rising alpha-fetoprotein (AFP) levels over 2 assessments, CT scan or MRI of liver, spiral CT scan of portal/splenic vein, and biopsy evidence of cirrhosis
* Unresectable or recurrent disease after prior surgical resection or embolization therapy
* Fibrolamellar histology allowed if considered surgically unresectable based on tumor size, extrahepatic involvement, or multiple lobe involvement
* CLIP (Cancer of the Liver Italian Program) score less than 4
* Concurrent assignment to a transplantation list allowed
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,200/mm\^3
* Platelet count at least 80,000/mm\^3
Hepatic:
* Bilirubin no greater than 3.0 mg/dL (except for known Gilbert's Syndrome)
* AST no greater than 5 times upper limit of normal (ULN)
* PT no greater than 1.5 times ULN
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No uncontrolled hypertension within the past 3 months
* No unstable angina, symptomatic congestive heart failure, or myocardial infarction within the past 3 months
* No uncontrolled cardiac arrhythmia
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active bacterial infections
* HIV negative
* No AIDS
* No other primary malignancy except carcinoma in situ of the cervix or urinary bladder or non-melanoma skin cancer
* No mental incapacitation or psychiatric illness that would preclude study participation
* No other severe disease that would preclude study participation
* Candidate for placement of a central venous access device
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior biologic therapy allowed
* No concurrent biologic therapy
Chemotherapy:
* No prior IV doxorubicin except intraarterial administration in locoregional therapy
Endocrine therapy:
* Prior endocrine therapy allowed
* No concurrent endocrine therapy
Radiotherapy:
* Prior radiotherapy allowed
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* Surgery allowed if previously unresectable lesions become resectable
* Recovered from any prior surgery
* No concurrent liver transplantation
Other:
* No other concurrent investigational or marketed anticancer drugs
* No other concurrent therapy for hepatocellular carcinoma
* No concurrent terfenadine, astemizole, or cisapride that may not be interrupted during nolatrexed dihydrochloride administration
18 Years
ALL
No
Sponsors
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Eximias Pharmaceutical
INDUSTRY
Principal Investigators
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Gregory R. Suplick
Role: STUDY_CHAIR
Eximias Pharmaceutical
Locations
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Arizona Clinical Research Center, Incorporated
Tucson, Arizona, 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
Scripps Cancer Center at Scripps Clinic
La Jolla, California, United States
David and Donna Long Center for Cancer Treatment at Sharp Grossmont Hospital
La Mesa, California, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States
California Pacific Medical Center - Pacific Campus
San Francisco, California, United States
Olive View - UCLA Medical Center Foundation
Sylmar, California, United States
California Hematology/Oncology Medical Group
Torrance, California, United States
Helen F. Graham Cancer Center
Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Florida Cancer Institute - Bayonet Point
Hudson, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Oncology-Hematology Group of South Florida, P.A.
Miami, Florida, United States
Ocala Research Institute, Incorporated
Ocala, Florida, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
University of Illinois at Chicago Cancer Center
Chicago, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Louisiana Oncology Associates - Lafayette
Lafayette, Louisiana, United States
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Saint Louis University Cancer Center
St Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Cancer Centers of the Carolinas - Eastside
Greenville, South Carolina, United States
Medical City Dallas Hospital
Dallas, Texas, 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
Princess Margaret Hospital
Toronto, Ontario, Canada
Fundacion de Investagacion De Diego
Santurce, , Puerto Rico
Countries
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References
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Gish RG, Porta C, Lazar L, Ruff P, Feld R, Croitoru A, Feun L, Jeziorski K, Leighton J, Gallo J, Kennealey GT. Phase III randomized controlled trial comparing the survival of patients with unresectable hepatocellular carcinoma treated with nolatrexed or doxorubicin. J Clin Oncol. 2007 Jul 20;25(21):3069-75. doi: 10.1200/JCO.2006.08.4046.
Other Identifiers
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CDR0000068506
Identifier Type: REGISTRY
Identifier Source: secondary_id
AG-337-301
Identifier Type: -
Identifier Source: secondary_id
ZARIX-ZX101-301
Identifier Type: -
Identifier Source: org_study_id
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