NCT00881816

Dose Escalation Study of Liposomal Paclitaxel Plus Capecitabine in Chinese Patients With Advanced Gastric Carcinoma

Phase I Clinical Study of Liposomal Paclitaxel Plus Capecitabine in Chinese Patients With Advanced Gastric Carcinoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Nanjing Sike Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose and dose limiting toxicity of liposomal paclitaxel plus capecitabine in Chinese patients with advanced gastric carcinoma.

Detailed description

There are clinical trials showed that taxane is optional for the treatment of gastric cancer. Liposomal paclitaxel has different pharmacokinetic features comparing with conventional taxane. This study is designed to find the maximum tolerated dose and dose limiting toxicity of liposomal paclitaxel combined with capecitabine in Chinese patients with advanced gastric carcinoma.

Conditions

• Advanced Gastric Carcinoma

Interventions

Type	Name	Description
DRUG	Liposomal paclitaxel plus capecitabine	All Patients will receive liposomal paclitaxel (with a dose of 60mg/m2,3h,ivgtt,at d1,8,15) and capecitabine (with a dose of 1600mg/m2,bid,po.,at d1-14),each cycle for 4 cycles.

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-10-01
• Completion: 2009-12-01
• First posted: 2009-04-15
• Last updated: 2009-04-15