Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer
Liver Cancer
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Sites / Locations
- Arizona Clinical Research Center, Incorporated
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Tower Cancer Research Foundation
- Scripps Cancer Center at Scripps Clinic
- David and Donna Long Center for Cancer Treatment at Sharp Grossmont Hospital
- Veterans Affairs Medical Center - Long Beach
- California Pacific Medical Center - Pacific Campus
- Olive View - UCLA Medical Center Foundation
- California Hematology/Oncology Medical Group
- Helen F. Graham Cancer Center
- Lombardi Cancer Center at Georgetown University Medical Center
- Florida Cancer Institute - Bayonet Point
- University of Miami Sylvester Comprehensive Cancer Center
- Oncology-Hematology Group of South Florida, P.A.
- Ocala Research Institute, Incorporated
- Cancer Research Center of Hawaii
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- University of Illinois at Chicago Cancer Center
- Holden Comprehensive Cancer Center at University of Iowa
- Louisiana Oncology Associates - Lafayette
- Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- University of Minnesota Cancer Center
- Saint Louis University Cancer Center
- Siteman Cancer Center at Barnes-Jewish Hospital
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Hackensack University Medical Center
- Veterans Affairs Medical Center - Albuquerque
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- New York Weill Cornell Cancer Center at Cornell University
- Herbert Irving Comprehensive Cancer Center at Columbia University
- SUNY Upstate Medical University Hospital
- New York Medical College
- Cleveland Clinic Taussig Cancer Center
- Albert Einstein Cancer Center
- Cancer Centers of the Carolinas - Eastside
- Medical City Dallas Hospital
- Joe Arrington Cancer Research and Treatment Center
- St. Boniface General Hospital
- Ottawa Hospital Regional Cancer Centre - General Campus
- Princess Margaret Hospital
- Fundacion de Investagacion De Diego