T900607 in Treating Patients With Gastroesophageal Junction Cancer
RATIONALE: Drugs used in chemotherapy work in 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 gastroesophageal junction cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Intravenous T900607-Sodium In Subjects With Previously Treated Gastric Carcinoma|
|Study Start Date:||September 2002|
|Study Completion Date:||September 2010|
|Primary Completion Date:||October 2004 (Final data collection date for primary outcome measure)|
- Determine the response rate (complete and partial) in patients with previously treated gastric or gastroesophageal junction carcinoma treated with T900607. (Gastric carcinoma closed to accrual as of 02/04.)
- Determine the duration of response and time to disease progression in patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the safety profile of this drug in these patients.
OUTLINE: This is an open-label, 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054249
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-1714|
|Study Chair:||Joanna M. Brell, MD||Case Comprehensive Cancer Center|