Dose Escalation Study of Liposomal Paclitaxel Plus Capecitabine in Chinese Patients With Advanced Gastric Carcinoma

April 14, 2009 updated by: Nanjing Sike Pharmaceutical Co., Ltd.

Phase I Clinical Study of Liposomal Paclitaxel Plus Capecitabine in Chinese Patients With Advanced Gastric Carcinoma

The purpose of this study is to determine the maximum tolerated dose and dose limiting toxicity of liposomal paclitaxel plus capecitabine in Chinese patients with advanced gastric carcinoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There are clinical trials showed that taxane is optional for the treatment of gastric cancer. Liposomal paclitaxel has different pharmacokinetic features comparing with conventional taxane. This study is designed to find the maximum tolerated dose and dose limiting toxicity of liposomal paclitaxel combined with capecitabine in Chinese patients with advanced gastric carcinoma.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18 to 75
  • Histologically or cytologically documented gastric adenocarcinoma and esophagus-gastro adenocarcinoma of metastatic or advanced stages with/without measurable tumor according to RECIST standard
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  • Patients who are expected to live at least 3 months
  • No prior systemic chemotherapy with advanced stereo- tumor before the recruitment(recidivist/ metastatic without perioperative chemotherapy at least 6m)
  • No Previous anaphylactic reaction to hormone
  • Obtaining informed consent
  • Patients may comply with the study protocol
  • Laboratory tests: Absolute neutrophil count (ANC) ≥2,000/mm³, Platelet count ≥100,000/mm³, Hemoglobin ≥9.0 g/dL, Serum creatinine≤1.5 x the institutional upper limit of normal (ULN), Creatinine clearance≥50ml/min，Total bilirubin≤1.5 x the institutional upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 x ULN. In the case of known liver metastasis, ALT and AST（SGOT） ≤1.5 x ULN.

Exclusion Criteria:

  • Active uncontrolled central nervous system metastasis

  • No adequate organ function or known disease :

    • myocardial infarction
    • active heart disease
    • neuropathy or mental diseases including dementia or epilepsy
    • blind、deaf、dumb or extremity disability
    • known infection
    • active diffuse intravascular coagulation
    • known infection with hepatitis virus
  • Pregnant or nursing,fertile patients would not use effective contraception during study treatment
  • Prior clinically significant gastrointestinal tract disease , that would influence obviously capecitabine to absorb,including the ability to swallow by the attending physician
  • No other active malignancies except that in complete remission with squamous cell carcinoma in situ of the cervix or anus, completely resected basal cell carcinoma, or no recrudescence for at least 2 year from the time a response was first documented
  • Having other study medication within 4w
  • Having radiation therapy or operation within 4w
  • Any non-remission toxicity ≥ CTC 1 in prior anticancer therapy(including radiation therapy) (except alopecie and hemoglobin)
  • Peripheral nerve disease ≥ 2
  • Previous anaphylactic reaction to Capecitabine and Paclitaxel or diluents bases
  • Absence of dihydropyrimidine dehydrogenase
  • Patients not suitable determined by the attending physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liposomal paclitaxel plus capecitabine
Drug: Liposomal paclitaxel plus capecitabine
All Patients will receive liposomal paclitaxel (with a dose of 60mg/m2,3h,ivgtt,at d1,8,15) and capecitabine (with a dose of 1600mg/m2,bid,po.,at d1-14),each cycle for 4 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maximum tolerated dose
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
dose limiting toxicity
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Sike Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Jin Li, Dr., Cancer Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

April 14, 2009

First Submitted That Met QC Criteria

April 14, 2009

First Posted (Estimate)

April 15, 2009

Study Record Updates

Last Update Posted (Estimate)

April 15, 2009

Last Update Submitted That Met QC Criteria

April 14, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPS-GC-02-2008
  • NJSK-LPS-PH I-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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