Stomach Neoplasms Clinical Trial
Official title:
A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma
This study is an open-label, single center, nonrandomized study, consisting of a
dose-escalating phase I study in advanced solid cancer and a subsequent phase II study in
metastatic gastric cancer. In phase I study, we aim to determine the MTD and the recommended
dose of S-1 combined with docetaxel given every 3 weeks. Dose level and escalating schedule
are followings
- S-1(level 0, 1/2, 3/4, 5: 60, 70, 80, 90 mg/m2/day) q 12 hours po Days 1-14)
- Docetaxel (level 0/1,2/3, 4/5: 25, 30, 35 mg/m2) mixed in d5w 200 ml iv over 60 min:
Days 1, 8with dexamethasone 8 mg po q 12hr for 3 days (total 6 doses: D0-2)and
parenteral pheniramine maleate 1 ample (45.5mg) before docetaxel
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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