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Raltitrexed and Paclitaxel for Gastric or Gastroesophageal Junction Adenocarcinoma

Primary Purpose

Gastric Cancer, Gastroesophageal Junction Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Raltitrexed
Paclitaxel
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Raltitrexed, Paclitaxel, chemotherapy, Gastric cancer, Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Raltitrexed and Paclitaxel

Arm Description

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

Outcomes

Primary Outcome Measures

Objective Response Rate

Secondary Outcome Measures

Overall Survival
From date of randomization until date of death
Progression-free survival
From date of randomization until date of first documented PD, date of death

Full Information

First Posted
March 14, 2017
Last Updated
January 29, 2021
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03083613
Brief Title
Raltitrexed and Paclitaxel for Gastric or Gastroesophageal Junction Adenocarcinoma
Official Title
Phase II Trial of Raltitrexed and Paclitaxel as Second-line Chemotherapy for Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Keywords
Raltitrexed, Paclitaxel, chemotherapy, Gastric cancer, Gastroesophageal Junction Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Raltitrexed and Paclitaxel
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Raltitrexed
Other Intervention Name(s)
RTX
Intervention Description
Raltitrexed:3mg/m2,iv,d1, Every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel:80mg/m2,iv,d1,d8, Every 3 weeks
Primary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
18-26 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
From date of randomization until date of death
Time Frame
18-26 months
Title
Progression-free survival
Description
From date of randomization until date of first documented PD, date of death
Time Frame
18-26 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ai Ping Zhou, Doctor of medcine
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
10000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Raltitrexed and Paclitaxel for Gastric or Gastroesophageal Junction Adenocarcinoma

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