This trial is active, not recruiting.

Condition gastric cancer
Treatments raltitrexed plus docetaxel, docetaxel
Phase phase 2
Sponsor Hebei Tumor Hospital
Start date April 2013
End date December 2016
Trial size 100 participants
Trial identifier NCT01836120, HBTH103


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
raltitrexed plus docetaxel
Raltitrexed plus Docetaxel (Raltitrexed 3mg/m2 d 1; Docetaxel 75mg/m2 d1, every 3 weeks, 4-6 cycles)
(Active Comparator)
Docetaxel (Docetaxel 75mg/m2 d1, every 3weeks,4-6 cycles)

Primary Outcomes

Progression-free survival (PFS)
time frame: 1 years

Secondary Outcomes

Objective Response Rate (ORR)
time frame: 1 year
Overall Survival (OS)
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Hebei Tumor Hospital.