drugset / Trial / NCT00980382
A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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
Timeline
- Start
- 2004-09
- Primary completion
- 2007-08
- Completion
- 2007-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 25 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 35 mg/m2 | Intravenous |
| Subject | S-1 | Small molecule | 60 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 70 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 80 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 90 mg/m2 | Oral |