A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer

Phase 2

• Conditions: Gastric Cancer
• Interventions: Drug: Raltitrexed plus Docetaxel; Drug: Docetaxel

• Registration Number: NCT01836120
• Lead Sponsor: Hebei Tumor Hospital

Brief Summary

A study of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with Gastric Cancer.The purpose of this study is to compare the activity of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with gastric carcinoma by estimating progression free survival (PFS) in each treatment arm.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-18
• Last Update Submitted: 2013-04-18
• Study First Posted: 2013-04-19
• Last Update Posted: 2013-04-19
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Signed informed consent form
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
3. Histologically or cytologically confirmed gastric cancer;
4. The first-line chemotherapy failure (required containing 5-fluorouracil)
5. At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
6. Life expectancy of at least 3 months;

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Exclusion Criteria

1. Received any prior treatment including Raltitrexed;
2. Active or uncontrolled infection;
3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
4. Pregnant or lactating women.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Raltitrexed plus Docetaxel	Raltitrexed plus Docetaxel	-
Docetaxel	Docetaxel	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	1 years

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	1 year
Overall Survival (OS)	1 year

Trial Locations

Locations (1)

Hebei Tumor Hospital; 🇨🇳 Shijiazhuang, Hebei, China