To hear about similar clinical trials, please enter your email below
Trial Title:
Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma
NCT ID:
NCT00639522
Condition:
Gastric Carcinoma
Conditions: Official terms:
Carcinoma
Stomach Neoplasms
Paclitaxel
Capecitabine
Conditions: Keywords:
Liposomal paclitaxel
Maximum tolerated dose
Pharmacokinetics
Gastric carcinoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Liposomal paclitaxel and capecitabine
Description:
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.
Arm group label:
A
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:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital,Chinese Academy of Medical Science
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinwan Wang, Doctor
Phone:
086-010-87788842
Email:
hsunyk@tom.com
Contact backup:
Last name:
Chi Yihebali, Doctor
Phone:
086-010-87788118
Email:
yihebalichi@yahoo.com.cn
Investigator:
Last name:
Jinwan Wang, Doctor
Email:
Principal Investigator
Start date:
May 2008
Completion date:
December 2009
Lead sponsor:
Agency:
Nanjing Sike Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Nanjing Sike Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00639522
