A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer

April 18, 2013 updated by: Hebei Tumor Hospital
A study of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with Gastric Cancer.The purpose of this study is to compare the activity of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with gastric carcinoma by estimating progression free survival (PFS) in each treatment arm.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Hebei Tumor Hospital

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:

  1. Signed informed consent form
  2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
  3. Histologically or cytologically confirmed gastric cancer;
  4. The first-line chemotherapy failure (required containing 5-fluorouracil)
  5. At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
  6. Life expectancy of at least 3 months;

Exclusion Criteria:

  1. Received any prior treatment including Raltitrexed;
  2. Active or uncontrolled infection;
  3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
  4. Pregnant or lactating women.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Docetaxel
Drug: Docetaxel
Docetaxel (Docetaxel 75mg/m2 d1, every 3weeks,4-6 cycles)
Experimental: Raltitrexed plus Docetaxel
Drug: Raltitrexed plus Docetaxel

Raltitrexed plus Docetaxel (Raltitrexed 3mg/m2 d

1; Docetaxel 75mg/m2 d1, every 3 weeks, 4-6 cycles)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: 1 years
1 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: 1 year
1 year
Objective Response Rate (ORR)
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Hebei Tumor Hospital

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, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

April 17, 2013

First Submitted That Met QC Criteria

April 18, 2013

First Posted (Estimate)

April 19, 2013

Study Record Updates

Last Update Posted (Estimate)

April 19, 2013

Last Update Submitted That Met QC Criteria

April 18, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBTH103

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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