Raltitrexed and Paclitaxel for Gastric or Gastroesophageal Junction Adenocarcinoma

NCT ID: NCT03083613

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-12-01

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.

Conditions

Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Raltitrexed

Intervention Type: DRUG

Raltitrexed:3mg/m2,iv,d1, Every 3 weeks

Paclitaxel

Intervention Type: DRUG

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

Interventions

Raltitrexed

Raltitrexed:3mg/m2,iv,d1, Every 3 weeks

Intervention Type: DRUG

Paclitaxel

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

Intervention Type: DRUG

Other Intervention Names

RTX

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Aiping Zhou

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ai Ping Zhou, Doctor of medcine

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Chinese Academy of Medical Sciences

Beijing, , China

Countries

China

Other Identifiers

CH-G1-070

Identifier Type: -

Identifier Source: org_study_id