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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. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Nanjing Sike Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00639522
First Posted: March 20, 2008
Last Update Posted: April 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nanjing Sike Pharmaceutical Co., Ltd.
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • Dose limiting toxicity [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 48 hours ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 14, 2008
First Posted: March 20, 2008
Last Update Posted: April 15, 2009
Last Verified: April 2009

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
Albumin-Bound Paclitaxel
Capecitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites