Status:
UNKNOWN
Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma
Lead Sponsor:
Nanjing Sike Pharmaceutical Co., Ltd.
Conditions:
Gastric Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00639522
Start Date
May 1 2008
End Date
December 1 2009
Last Update
April 15 2009
Active Locations (1)
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1
Cancer Hospital,Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021