Dolastatin 10 in Treating Patients With Metastatic Or Recurrent Liver, Bile Duct, or Gallbladder 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 advanced adult primary liver cancer, recurrent adult primary liver cancer, unresectable gallbladder cancer, recurrent gallbladder cancer, unresectable extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, adult primary hepatocellular carcinoma, cholangiocarcinoma of the gallbladder
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic, locally advanced, or recurrent cancer of the liver (hepatoma), bile duct, or gallbladder (cholangiocarcinoma) Bidimensionally measurable disease The following are not considered measurable lesions: Lesions seen on colonoscopic examination or barium studies Bone metastases CNS lesions CEA, CA19-9, or AFP levels Ascites No CNS disease only No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 OR Platelet count at least 75,000/mm3 in patients with clinically documented sequestration or hemodilution unrelated to primary bone marrow insufficiency Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant underlying medical or psychiatric illness No active infections No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer and carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced or metastatic hepatobiliary cancer No other concurrent chemotherapy No concurrent investigational antineoplastic drugs Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to only site of measurable disease At least 6 weeks since prior radiotherapy and recovered No concurrent radiotherapy to any lesion Surgery: Not specified
Sites / Locations
- University of Illinois at Chicago
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- Cancer Care Specialists of Central Illinois, S.C.
- Evanston Northwestern Health Care
- Lutheran General Cancer Care Center
- Illinois Oncology Research Association
- Central Illinois Hematology Oncology Center
- Fort Wayne Medical Oncology and Hematology, Inc.
- Michiana Hematology/Oncology P.C.
- University of Texas - MD Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Arm A
Dolastatin-10 (400 mcg/m2 IV every 3 weeks)