A Phase I/II Trial of Docetaxel and Oxaliplatin in Patients With Advanced Gastric Cancer
Primary objectives :
To define the dose-limiting toxicity and maximum tolerated dose in phase I study To evaluate
the overall response rate in phase II study
Secondary objectives :
1. To evaluate the safety and tolerability of the treatment combination.
2. To estimate overall survival.
3. To estimate the time to progression and the duration of overall response.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To define the dose-limiting toxicity and maximum tolerated dose in phase I study To evaluate the overall response rate in phase II study
Two years
Yes
Young Suk Park, M.D., Ph.D.
Principal Investigator
Samsung Medical Center, Seoul, KOREA
Korea: Food and Drug Administration
2005-10-047
NCT00533533
January 2006
June 2008
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