NCT00980382

A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	S-1, Docetaxel	* Phase I study * 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) iv : Days 1, 8 * Phase II study * S-1 (80mg/m2/day) q 12 hours po Days 1-14 * Docetaxel (35 mg/m2) iv : Days 1, 8

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2009-09-21
• Last updated: 2009-09-21

Locations

1 site across 1 country: South Korea