Back to resultsA Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Raltitrexed plus Docetaxel
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring second-line chemotherapy, Raltitrexed
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent form
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
- Histologically or cytologically confirmed gastric cancer;
- The first-line chemotherapy failure (required containing 5-fluorouracil)
- At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
- Life expectancy of at least 3 months;
Exclusion Criteria:
- Received any prior treatment including Raltitrexed;
- Active or uncontrolled infection;
- Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
- Pregnant or lactating women.
Sites / Locations
- Hebei Tumor Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Raltitrexed plus Docetaxel
Docetaxel
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
Secondary Outcome Measures
Objective Response Rate (ORR)
Overall Survival (OS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01836120
Brief Title
A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer
Official Title
A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Tumor Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
second-line chemotherapy, Raltitrexed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Raltitrexed plus Docetaxel
Arm Type
Experimental
Arm Title
Docetaxel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Raltitrexed plus Docetaxel
Intervention Description
Raltitrexed plus Docetaxel (Raltitrexed 3mg/m2 d
1; Docetaxel 75mg/m2 d1, every 3 weeks, 4-6 cycles)
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel (Docetaxel 75mg/m2 d1, every 3weeks,4-6 cycles)
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
1 year
Title
Overall Survival (OS)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent form
Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
Histologically or cytologically confirmed gastric cancer;
The first-line chemotherapy failure (required containing 5-fluorouracil)
At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
Life expectancy of at least 3 months;
Exclusion Criteria:
Received any prior treatment including Raltitrexed;
Active or uncontrolled infection;
Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
Pregnant or lactating women.
Facility Information:
Facility Name
Hebei Tumor Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer
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