Phase I/II Study of S-1, Cisplatin and Docetaxel in Patients with Advanced Gastric Cancer

UMIN ID: UMIN000000484

Registered date:11/09/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: untreated advanced or recurrent gastric cancer
• Date of first enrollment: 2006/08/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Cisplatin, Day1 Level 0: 30mg/m2 Level 1: 40mg/m2 Level 2: 50mg/m2 Level 3: 60mg/m2 S-1 (80mg/m2), Day1-14, 22-35 Docetaxel (40mg/m2), Day22 Repeat every 6 weeks

Outcome(s)

• Primary Outcome: Phase I: Maximum Tolerated Dose, Recommended dose Phase II: Response rate
• Secondary Outcome: Toxicity, Progression free survival, Overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Active other malignancy 2) Interstitial pneumonitis, pulmonary fibrosis 3) Massive pleural effusion or massive ascites 4) Active infection 5) Watery diarrhea 6) Other uncontrolled severe illness 7) Brain metastases 8) Pregnant or lactating women 9) Not appropriate for the study at the physician's assessment

Related Information

• Primary Sponsor: Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama
• Source(s) of Monetary Support: Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama