Raltitrexed and Paclitaxel for Gastric or Gastroesophageal Junction Adenocarcinoma

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT03083613

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Gastroesophageal Junction Adenocarcinoma	Drug: Raltitrexed Drug: Paclitaxel	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2015

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Objective Response Rate [18-26 months]

Secondary Outcome Measures

Overall Survival [18-26 months]
From date of randomization until date of death
Progression-free survival [18-26 months]
From date of randomization until date of first documented PD, date of death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.