T900607 in Treating Patients With Unresectable Liver Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Intravenous T900607-Sodium In Subjects With Chemotherapy-Naive Unresectable Hepatocellular Carcinoma|
|Study Start Date:||November 2002|
|Study Completion Date:||September 2010|
|Primary Completion Date:||March 2004 (Final data collection date for primary outcome measure)|
- 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.
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-1714|
|Study Chair:||Joanna M. Brell, MD||Case Comprehensive Cancer Center|