t900607 in treating patients with unresectable liver cancer

Conditions: Liver Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of t900607 in treating patients who have unresectable liver cancer.

objectives: * determine the complete and partial response rates of patients with chemotherapy-naïve unresectable hepatocellular carcinoma treated with t900607. * determine the efficacy of this drug, in terms of duration of response and time to disease progression, in these patients. * determine the pharmacokinetics of this drug in these patients. * determine the safety profile of this drug in these patients. outline: this is a multicenter study. patients receive t900607 iv over 1 hour once weekly. treatment continues in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months. projected accrual: a total of 20-35 patients will be accrued for this study.

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

Keywords: localized unresectable adult primary liver cancer advanced adult primary liver cancer adult primary hepatocellular carcinoma