Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
About this trial
This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring localized unresectable adult primary liver cancer, advanced adult primary liver cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer, adult primary hepatocellular carcinoma, cholangiocarcinoma of the gallbladder, cholangiocarcinoma of the extrahepatic bile duct, adult primary cholangiocellular carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of advanced hepatobiliary carcinoma not amenable to conventional surgery Gall bladder carcinoma Cholangiocarcinoma Carcinoma of the ampulla Hepatocellular carcinoma (eligible for cohort II only) Measurable disease No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm^3 Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin less than 3 mg/dL Cohort I (closed to accrual as of 11/1/03) Bilirubin no greater than 1.5 mg/dL AST no greater than 2.5 times upper limit of normal (ULN) Cohort II Bilirubin greater than 1.5 mg/dL and less than 3 mg/dL OR Bilirubin no greater 1.5 mg/dL AND AST greater than 2.5 times ULN Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for cholangiocarcinoma or hepatobiliary carcinoma Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent combination antiviral therapy for HIV-positive patients
Sites / Locations
- Comprehensive Cancer Center at University of Alabama at Birmingham
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
- Hillman Cancer Center at University of Pittsburgh Cancer Institute