Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma
NCT ID: NCT00639522
Last Updated: 2009-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
18 participants
INTERVENTIONAL
2008-05-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
65 Years
ALL
No
Sponsors
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Nanjing Sike Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Cancer Institute and Hospital,Chinese Academy of Medical Science
Principal Investigators
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Jinwan Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital Chinese Academy of Medical Science
Locations
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Cancer Hospital,Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LPS-GC-01-2008
Identifier Type: -
Identifier Source: org_study_id
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