Gastric Carcinoma
Conditions
Keywords
Liposomal paclitaxel, Maximum tolerated dose, Pharmacokinetics, Gastric carcinoma
Brief 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.
Interventions
DRUGLiposomal 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.
Sponsors
Nanjing Sike Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | 48 hours |
Countries
China
Contacts
Primary ContactJinwan Wang, Doctor
Backup ContactChi Yihebali, Doctor
Outcome results
None listed