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

Inclusion 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