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Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Nanjing Sike Pharmaceutical Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nanjing Sike Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00639522
First received: March 14, 2008
Last updated: April 14, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastric Carcinoma
 Drug: Liposomal paclitaxel and capecitabine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial to Investigate the Maximum Tolerated Dose and Pharmacokinetics of Liposomal Paclitaxel With/Without Capecitabine in Chinese Cancer Patients With Advanced Gastric Carcinoma.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nanjing Sike Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Dose limiting toxicity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: May 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639522

Contacts
Contact: Jinwan Wang, Doctor 086-010-87788842 hsunyk@tom.com
Contact: Chi Yihebali, Doctor 086-010-87788118 yihebalichi@yahoo.com.cn

Locations
China, Beijing
Cancer Hospital,Chinese Academy of Medical Science Recruiting
Beijing, Beijing, China, 100021
Contact: Jinwan Wang, Doctor     086-010-87788842     hsunyk@tom.com    
Contact: Chi Yihebali, Doctor     086-010-87788118     yihebalichi@yahoo.com.cn    
Principal Investigator: Jinwan Wang, Doctor            
Sponsors and Collaborators
Nanjing Sike Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Jinwan Wang, Doctor Cancer Hospital, Chinese Academy of Medical Science
  More Information

No publications provided

Responsible Party: Prof. Jinwan Wang, Cancer Institute and Hospital,Chinese Academy of Medical Science
ClinicalTrials.gov Identifier: NCT00639522     History of Changes
Other Study ID Numbers: LPS-GC-01-2008
Study First Received: March 14, 2008
Last Updated: April 14, 2009
Health Authority: China: Ministry of Health

Keywords provided by Nanjing Sike Pharmaceutical Co., Ltd.:
Liposomal paclitaxel
Maximum tolerated dose
Pharmacokinetics
Gastric carcinoma

Additional relevant MeSH terms:
Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Capecitabine
Fluorouracil
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013