Phase I/II study of intravenous and intraperitoneal paclitaxel combined with continuous intraperitoneal cisplatin for advanced gastric cancer with peritoneal metastasis

UMIN ID: UMIN000002257

Registered date:01/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: advanced gastric cancer with peritoneal metastasis
• Date of first enrollment: 2009/06/01
• Target sample size: 25
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): In the phase I study, paclitaxel is administered intravenously on days 1 and 15 at a fixed dose of 100 mg/m2, and intraperitoneally with an initial dose of 20 mg/m2, stepped up to 30 or 40 mg/m2. Cisplatin is administered intraperitoneally over 1 hour at a fixed dose of 30 mg/m2. In the phase II study, paclitaxel is administered intraperitoneally at the recommended dose.

Outcome(s)

• Primary Outcome: safety the 1-year overall survival rate
• Secondary Outcome: the overall response rate, efficacy against peritoneal metastasis and safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Metastasis to distant organ sites (such as the liver, lungs or bone), other active concomitant malignancies, or other severe medical conditions.

Related Information

• Primary Sponsor: Department of Surgical Oncology, The University of Tokyo
• Source(s) of Monetary Support: The Ministry of Health, Labor and Welfare of Japan