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

Advanced Gastric Cancer Clinical Trial

Official title:

Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer Stage II Randomized Controlled Clinical Studies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02072317
• Other study ID #: guoweijian-2013-raltitrexed
• Status: Recruiting
• Phase: Phase 2
• First received: February 24, 2014
• Last updated: February 24, 2014
• Start date: November 2013
• Est. completion date: March 2016

Study information

• Verified date: February 2014
• Source: Fudan University
• Contact: GUO WEI JIAN, doctor
• Phone: 13816066360
• Email: guoweijian1[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• taxel plus raltitrexed
taxol 135 mg/m2, raltitrexed 3 mg/m2 ivgtt d1, every three weeks for a cycle
• taxol
taxol 135 mg/m2, every three weeks for a cycle

Locations

Country	Name	City	State
China	Cancer hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		Since the date of random to disease progression or any cause of death,the average time is 2 years	Yes