Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma
Conditions
Gastric Carcinoma
Conditions: official terms
Carcinoma - Stomach Neoplasms
Conditions: Keywords
Liposomal paclitaxel, Maximum tolerated dose, Pharmacokinetics, Gastric carcinoma
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Liposomal paclitaxel and capecitabine
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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;
Location
Cancer Hospital,Chinese Academy of Medical Science
Beijing, Beijing, China
Status: Recruiting
Contact: Jinwan Wang, Doctor - 086-010-87788842 - hsunyk@tom.com
Start Date
May 2008
Completion Date
December 2009
Sponsors
Nanjing Sike Pharmaceutical Co., Ltd.
Source
Nanjing Sike Pharmaceutical Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page