A Phase I Clinical Trial to Investigate the Maximum Tolerated Dose and Pharmacokinetics of Liposomal Paclitaxel With/Without Capecitabine in Chinese Cancer Patients With Advanced Gastric Carcinoma.
The maximum tolerated dose (MTD) and pharmacokinetics of a new formulation of taxane
(liposomal paclitaxel) have never been studied in Chinese cancer patients, either alone or
with capecitabine .This clinical trial is designed to find out the MTD and pharmacokinetics
of liposomal paclitaxel with a beginning dose of 175mg/m2 with/without Capecitabine in
Chinese patients with advanced gastric carcinoma.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose limiting toxicity
6 weeks
Yes
Jinwan Wang, Doctor
Principal Investigator
Cancer Hospital, Chinese Academy of Medical Science
China: Ministry of Health
LPS-GC-01-2008
NCT00639522
May 2008
December 2009
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