A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hepatocellular Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed hepatocellular carcinoma with or without
evidence of unresectable extrahepatic metastasis Previously untreated disease OR
Progressive disease after first line chemotherapy Bidimensionally measurable disease by CT
scan, chest x-ray, or MRI of the abdomen No brain metastases

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 80,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2.0
mg/dL Albumin at least 2.8 g/dL SGOT/SGPT no greater than 5 times upper limit of normal
(ULN) PT/INR no greater than 1.5 times ULN if not on coumadin therapy Renal: Creatinine no
greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled
angina No myocardial infarction within the past 6 months Other: No concurrent serious
infection No other life threatening illness No overt psychosis or mental disability that
would preclude informed consent No other malignancy within the past 5 years except
curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception 1 month prior to and during the study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy:
See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No
prior camptothecin analogues No other concurrent chemotherapy Endocrine therapy: Not
specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No
concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered
No concurrent surgery Other: No other concurrent anticancer therapy At least 4 weeks since
prior investigational drugs (including analgesics or antiemetics) No other investigational
drugs during or within 28 days after final dose of study drug