Raltitrexed and Paclitaxel for Gastric or Gastroesophageal Junction Adenocarcinoma

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083613
• Other study ID #: CH-G1-070
• Status: Completed
• Phase: Phase 2
• Start date: May 2015
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2021
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 1, 2018
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate		18-26 months
Secondary	Overall Survival	From date of randomization until date of death	18-26 months
Secondary	Progression-free survival	From date of randomization until date of first documented PD, date of death	18-26 months