A Phase II Trial of Dolastatin-10 (NSC 376128) Administered as an IV Bolus Every 3 Weeks in Patients With Hepatobiliary Cancer

Date de début de l'étude : 1 janvier 1999

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