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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Advanced Gastric Cancer

Treatments: Drug: taxel plus raltitrexed; Drug: taxol

Study type: Interventional

Funder types: Other

Identifiers

NCT02072317

guoweijian-2013-raltitrexed

Details and patient eligibility

About

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

Full description

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

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Paclitaxel plus raltitrexed

Experimental group

Description:

taxol 135 mg/m2, raltitrexed 3 mg/m2 ivgtt d1, every three weeks for a cycle

Treatment:

Drug: taxel plus raltitrexed

taxol

Active Comparator group

Description:

taxol 135 mg/m2, every three weeks for a cycle

Treatment:

Drug: taxol