NCT00639522

Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma

A Phase I Clinical Trial to Investigate the Maximum Tolerated Dose and Pharmacokinetics of Liposomal Paclitaxel With/Without Capecitabine in Chinese Cancer Patients With Advanced Gastric Carcinoma.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Nanjing Sike Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the maximum tolerated dose and pharmacokinetics of liposomal paclitaxel with/without capecitabine in Chinese cancer patients with advanced gastric carcinoma.

Detailed description

The maximum tolerated dose (MTD) and pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) have never been studied in Chinese cancer patients, either alone or with capecitabine .This clinical trial is designed to find out the MTD and pharmacokinetics of liposomal paclitaxel with a beginning dose of 175mg/m2 with/without Capecitabine in Chinese patients with advanced gastric carcinoma.

Conditions

• Gastric Carcinoma

Interventions

Type	Name	Description
DRUG	Liposomal paclitaxel and capecitabine	Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2、185mg/m2、195mg/m2、 200mg/m2、205mg/m2 and so on ,at the first day of chemotherapy. Capecitabine will be given on d1 to d14 with the dose of 185mg/m2、200mg/m2 or d8 to d21 with the dose of 175mg/m2、195mg/m2、205mg/m2 .Cycle duration will be 21 days. Each patient will receive 2 cycles of therapy. Only in the first cycle blood samples will be taken on 16 points in 48 hours after the infusion of liposomal paclitaxel.

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2008-03-20
• Last updated: 2009-04-15

Locations

1 site across 1 country: China