T900607 in Treating Patients With Unresectable Liver Cancer
Liver Cancer
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adult primary hepatocellular carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable hepatocellular carcinoma (HCC) Bidimensionally measurable disease defined as at least 1 lesion that is 1 cm or more in 2 dimensions by CT scan Class A or B Child-Pugh liver classification No prior CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 70-100% Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3* Platelet count at least 100,000/mm^3* Hemoglobin at least 8.5 g/dL* NOTE: *More than 7 days since prior blood transfusions or growth factors Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) Albumin greater than 2.5 g/dL AST and ALT no greater than 3 times ULN INR no greater than 1.5 (unless receiving anticoagulants) Renal Creatinine no greater than 2 times ULN Cardiovascular LVEF at least 50% No New York Heart Association class III or IV cardiac disease No acute anginal symptoms Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No severe concurrent disease, infection, or co-morbidity that would preclude study entry No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy for HCC No concurrent therapeutic biological response modifier Chemotherapy No prior chemotherapy for HCC No prior chemoembolization for HCC No other concurrent cytotoxic chemotherapy Endocrine therapy At least 6 weeks since prior hormonal therapy (an indicator lesion must exist outside the area of therapy No concurrent hormonal anticancer therapy Radiotherapy No prior radiotherapy for HCC At least 6 weeks since prior radiofrequency ablation, selective internal radiation, or embolization (an indicator lesion must exist outside the area of therapy) No concurrent radiotherapy (including palliative therapy) Surgery At least 6 weeks since prior surgical resection (an indicator lesion must exist outside the area of therapy) Recurrence at the margin of the surgical resection is allowed At least 6 weeks since prior cryosurgery More than 4 weeks since other prior major surgery Other More than 4 weeks since prior investigational therapy At least 6 weeks since prior intratumoral ethanol injection (an indicator lesion must exist outside the area of therapy) No other concurrent investigational anticancer therapy
Sites / Locations
- Ireland Cancer Center