T900607 in Treating Patients With Unresectable Liver Cancer
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|ClinicalTrials.gov Identifier: NCT00054262|
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : July 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: T900607||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Intravenous T900607-Sodium In Subjects With Chemotherapy-Naive Unresectable Hepatocellular Carcinoma|
|Study Start Date :||November 2002|
|Primary Completion Date :||March 2004|
|Study Completion Date :||September 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054262
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-1714|
|Study Chair:||Joanna M. Brell, MD||Case Comprehensive Cancer Center|