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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01836120
• Other study ID #: HBTH103
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 17, 2013
• Last updated: April 18, 2013
• Start date: April 2013
• Est. completion date: June 2017

Study information

• Verified date: April 2013
• Source: Hebei Tumor Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Food and Drug Adminstration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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;

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Raltitrexed plus Docetaxel
Raltitrexed plus Docetaxel (Raltitrexed 3mg/m2 d 1; Docetaxel 75mg/m2 d1, every 3 weeks, 4-6 cycles)
• Docetaxel
Docetaxel (Docetaxel 75mg/m2 d1, every 3weeks,4-6 cycles)

Locations

Country	Name	City	State
China	Hebei Tumor Hospital	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		1 years	Yes
Secondary	Objective Response Rate (ORR)		1 year	Yes
Secondary	Overall Survival (OS)		1 year	Yes