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

Primary Purpose

Gastric Carcinoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Liposomal paclitaxel and capecitabine
Sponsored by
Nanjing Sike Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Carcinoma focused on measuring Liposomal paclitaxel, Maximum tolerated dose, Pharmacokinetics, Gastric carcinoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Cancer Hospital,Chinese Academy of Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Dose limiting toxicity

Secondary Outcome Measures

Pharmacokinetics

Full Information

First Posted
March 14, 2008
Last Updated
April 14, 2009
Sponsor
Nanjing Sike Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00639522
Brief Title
Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing Sike Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Carcinoma
Keywords
Liposomal paclitaxel, Maximum tolerated dose, Pharmacokinetics, Gastric carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Liposomal paclitaxel and capecitabine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dose limiting toxicity
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinwan Wang, Doctor
Phone
086-010-87788842
Email
hsunyk@tom.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chi Yihebali, Doctor
Phone
086-010-87788118
Email
yihebalichi@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinwan Wang, Doctor
Organizational Affiliation
Cancer Hospital, Chinese Academy of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital,Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinwan Wang, Doctor
Phone
086-010-87788842
Email
hsunyk@tom.com
First Name & Middle Initial & Last Name & Degree
Chi Yihebali, Doctor
Phone
086-010-87788118
Email
yihebalichi@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Jinwan Wang, Doctor

12. IPD Sharing Statement

Learn more about this trial

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

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