SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed hepatocellular carcinoma
• •* Locally advanced, recurrent, or metastatic disease
• •* Histologically confirmed disease must have archival paraffin-fixed tumor specimen available
• •Measurable disease
• •* At least 1 unidimensionally measurable site of disease ≥ 20 mm by x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm by spiral CT scan
• •* Outside of previously irradiated area
• •* Patients whose sole site of disease is in a previously irradiated field are eligible provided there is evidence of disease progression OR new lesions documented in the irradiated field
• •* Bone metastases are not considered measurable disease
• •Not curable by standard therapies
• •No cholangiocarcinoma
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •At least 12 weeks
• •Hematopoietic
• •Absolute granulocyte count ≥ 1,500/mm\^3
• •Platelet count ≥ 80,000/mm\^3
• •Hepatic
• •Bilirubin ≤ 2 times upper limit of normal (ULN)
• •AST ≤ 5 times ULN
• •Must have hepatic reserve of Child-Turcotte-Pugh class A or better
• •Renal
• •Creatinine clearance ≥ 60 mL/min
• •Cardiovascular
• •No myocardial infarction within the past 6 months
• •No symptomatic congestive heart failure
• •No unstable angina pectoris
• •No cardiac arrhythmia
• •No active cardiomyopathy
• •No uncontrolled hypertension
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No clinical evidence of encephalopathy
• •No ongoing or active infection
• •No history of allergic reaction attributed to compounds of similar chemical or biological composition to SB-715992
• •No psychiatric illness or social situation that would preclude study compliance
• •No other uncontrolled illness
• •No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Not specified
• •Chemotherapy
• •At least 4 weeks since prior intra-hepatic chemotherapy as a component of trans-arterial chemoembolization and recovered
• •* Documented disease progression
• •No prior systemic chemotherapy
• •Endocrine therapy
• •Not specified
• •Radiotherapy
• •See Disease Characteristics
• •At least 4 weeks since prior radiotherapy
• •* Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy
• •Surgery
• •At least 4 weeks since prior major surgery
• •Prior liver transplantation allowed
• •Other
• •No other prior systemic therapy
• •At least 4 weeks since prior local ablative therapy (e.g., radiofrequency ablation or ethanol injection) and recovered
• •* Documented disease progression
• •More than 28 days since prior investigational agents
• •More than 14 days since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:
• •* Clarithromycin
• •* Erythromycin
• •* Troleandomycin
• •* Itraconazole
• •* Ketoconazole
• •* Fluconazole (dose \> 200 mg/day)
• •* Voriconazole
• •* Nefazodone
• •* Fluvoxamine
• •* Verapamil
• •* Diltiazem
• •* Grapefruit juice
• •* Bitter orange
• •* Phenytoin
• •* Carbamazepine
• •* Phenobarbital
• •* Oxcarbazepine
• •* Rifampin
• •* Rifabutin
• •* Rifapentine
• •* Hypericum perforatum (St. John's wort)
• •* Modafinil
• •At least 6 months since prior and no concurrent amiodarone
• •No concurrent combination antiretroviral therapy for HIV-positive patients
• •No other concurrent anticancer therapy
• •No other concurrent investigational agents