Raltitrexed and Paclitaxel for Gastric or Gastroesophageal Junction Adenocarcinoma

January 29, 2021 updated by: Aiping Zhou, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase II Trial of Raltitrexed and Paclitaxel as Second-line Chemotherapy for Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This is a single-arm clinical trial.The purpose of this study is to evaluate the efficacy and safety of Raltitrexed and Paclitaxel as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma .The primary endpoint of this study is objective response rate.The secondary endpoint of this study is safety,progression-free survival and overall survival.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Raltitrexed is an antifolate thymidylate synthase inhibitor that has shown efficacy and good safety profile in the treatment of colorectal cancer. To our knowledge, there has been no study published with the Raltitrexed and Paclitaxel regimen as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.The aim of our study was to evaluate the efficacy, safety and survival of this regimen in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Study Type

Interventional

Enrollment (Actual)

41

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
      • Beijing, China, 10000
        • Chinese Academy of Medical Sciences

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:

  • Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
  • Patients failed first-line chemotherapy containing fluoropyrimidines and platinums;
  • ECOG (Eastern Cooperative Oncology Group)performance status 0-1;
  • At least 1 measurable lesion should be present（RECIST1.1）
  • Available Organ function: Neutrophils>2g/L, Hemoglobin>9g/L, Blood platelet >100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)<1.0 ULN; Cr <1.0ULN
  • Signed informed consent.
  • Life expectancy ≥3 months;

Exclusion Criteria:

  • Previous treatment with Raltitrexed or Paclitaxel;
  • Known history of allergic reaction to Raltitrexed or Paclitaxel;
  • Known brain metastases;
  • Pregnant or breast feeding women;
  • Severe diarrhea,intestinal obstruction;
  • other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix);
  • Previous myocardial infarction, unstable angina, stroke ,or uncontrollable Arrhythmia;
  • Kown HIV infecton.

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: Raltitrexed and Paclitaxel

All patients receive the combination therapy of Raltitrexed and Paclitaxel for a maximum of 6 cycles

Raltitrexed:3mg/m2,d1 Paclitaxel:80mg/m2,d1,d8,

Eery 3 weeks
Drug: Raltitrexed
Raltitrexed:3mg/m2,iv,d1, Every 3 weeks
Other Names:
  • RTX
Drug: Paclitaxel
Paclitaxel:80mg/m2,iv,d1,d8, Every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: 18-26 months
18-26 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 18-26 months
From date of randomization until date of death
18-26 months
Progression-free survival
Time Frame: 18-26 months
From date of randomization until date of first documented PD, date of death
18-26 months

Collaborators and Investigators

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Ai Ping Zhou, Doctor of medcine, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

May 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

March 14, 2017

First Posted (Actual)

March 20, 2017

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 29, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-G1-070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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