Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer

Phase 2

• Conditions: Advanced Gastric Cancer
• Interventions: Drug: taxel plus raltitrexed; Drug: taxol

• Registration Number: NCT02072317
• Lead Sponsor: Fudan University

Brief Summary

The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy in Paclitaxel plus raltitrexed plug compare with taxol second-line treatment for advanced gastric cancer

Detailed Description

from the first cycle of treatment (day one) to two month after the last cycle

Study Timeline

• Study Start: 2013-11
• Status Verified: 2014-02
• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-02-24
• Last Update Submitted: 2014-02-24
• Study First Posted: 2014-02-26
• Last Update Posted: 2014-02-26
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1.18~75 years old 2.Pathological diagnosis of gastric cancer or gastroesophageal junction adenocarcinoma 3.patient failed after The first line treatment of 5-Fu and platinum ,patient relapse half year after using 5 - Fu and platinum as Postoperative adjuvant chemotherapy 4.ECOG 0-1 5.At least one measurable objective tumor lesions 6.ANC≥1.5*109/L；PLT≥80*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤1.5ULN； Cr≤ULN；Ccr≥60ml/min 7.Expected survival period for 3 months or more 8. patients with voluntary participation, and sign the informed consent

Exclusion Criteria

1. Recurrence after transfer have received taxol or docetaxel as first-line chemotherapy,If the adjuvant chemotherapy with paclitaxel,From the last chemotherapy for 6 months or less
2. With uncontrollable large pleural or peritoneal effusion
3. In the near future has a history of myocardial infarction (3 months)
4. Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas;
5. With brain metastasis
6. Severe uncontrolled medical disease or acute infection
7. Pregnancy or breast-feeding women
8. Has a long history of chronic diarrhea, or now complete intestinal obstruction patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paclitaxel plus raltitrexed	taxel plus raltitrexed	taxol 135 mg/m2, raltitrexed 3 mg/m2 ivgtt d1, every three weeks for a cycle
taxol	taxol	taxol 135 mg/m2, every three weeks for a cycle

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Since the date of random to disease progression or any cause of death，the average time is 2 years

Trial Locations

Locations (1)

Cancer hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China