SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer
Liver Cancer
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
Eligibility 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
Sites / Locations
- BCCA - Vancouver Cancer Centre
- Juravinski Cancer Centre at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston
- Univ. Health Network-Princess Margaret Hospital