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

Gastric Carcinoma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00639522
• Other study ID #: LPS-GC-01-2008
• Status: Recruiting
• Phase: Phase 1
• First received: March 14, 2008
• Last updated: April 14, 2009
• Start date: May 2008
• Est. completion date: December 2009

Study information

• Verified date: April 2009
• Source: Nanjing Sike Pharmaceutical Co., Ltd.
• Contact: Jinwan Wang, Doctor
• Phone: 086-010-87788842
• Email: hsunyk[@]tom.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Histologically verified gastric carcinoma of advanced stages which is unsuitable for surgery;

• No prior systemic chemotherapy with taxane at least 6 months before the recruitment;

• At least one measurable tumor according to RECIST standard, with at least one diameter =20mm assessed by traditional imaging technique or MRI, or with a diameter twice of the thickness of scan layer (or =10-16mm) under spiral CT; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;

• Patients who are expected to live at least 3 months;

• Obtaining informed consent;

Exclusion Criteria:

• Receiving other chemotherapy or radiotherapy during the administration;

• Symptomatic metastatic brain tumor;

• Allergy to any study medication;

• Pregnancy or breast feeding;

• Severe heart diseases;

• Uncontrolled mental diseases;

• Abnormal liver and renal functions, which are measured by AST/ALT and BUN/Cr;

• Neutrophils(ANC)<2000/µL;platelets<100,000/µL;hemoglobin(HB)<9.0 g/dL;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Gastric Carcinoma
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Cancer Hospital,Chinese Academy of Medical Science	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Sike Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity		6 weeks	Yes
Secondary	Pharmacokinetics		48 hours	No