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Brief Title: T900607 in Treating Patients With Unresectable Liver Cancer
Official Title: A Phase II Study Of Intravenous T900607-Sodium In Subjects With Chemotherapy-Naive Unresectable Hepatocellular Carcinoma
Study ID: NCT00054262
Brief 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ireland Cancer Center, Cleveland, Ohio, United States
Name: Joanna M. Brell, MD
Affiliation: Case Comprehensive Cancer Center
Role: STUDY_CHAIR