Raltitrexed and Paclitaxel for Gastric or Gastroesophageal Junction Adenocarcinoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastric Cancer, Gastroesophageal Junction Adenocarcinoma

Intervention / Treatment
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* Drug: Raltitrexed
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raltitrexed and Paclitaxel<br>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<br>* Raltitrexed:3mg/m2,iv,d1, Every 3 weeks<br>* Other names: RTX;Drug: Paclitaxel<br>* Paclitaxel:80mg/m2,iv,d1,d8, Every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | 18-26 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Raltitrexed, Paclitaxel, chemotherapy, Gastric cancer, Gastroesophageal Junction Adenocarcinoma