Back to resultsCombination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Suspended
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Capecitabine and Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Advanced gastric cancer, Response rate, Side effects, time to progression, overall survival
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 70 years
- Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma
- ECOG performance status ≤1
- Measurable diseases according to the RECIST
- Relapse or refractory after the first-line chemotherapy
- Sign ICF,normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).
Exclusion Criteria:
- Relapse within 6 months after adjuvant chemotherapy which contained oxaliplatin
- Have used any of drugs in the regimen in first-line chemotherapy
- Pregnant or lactating women,serious uncontrolled diseases and intercurrent infection
- The evidence of CNS metastasis
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Received other chemotherapy regimen after metastasis
- Participated in other clinical trials.
Sites / Locations
- Fudan University Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Combine Chemotherapy
Arm Description
XELOX(Xeloda and oxaliplatin combination)
Outcomes
Primary Outcome Measures
Response Rate
Secondary Outcome Measures
time to progression and overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00568529
Brief Title
Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer
Official Title
Phase II Study on Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Suspended
Why Stopped
There are not enough patients enrolled.
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
February 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and overall survival of the regimen of XELOX (Xeloda and oxaliplatin combination) in the patients with relapsed and refractory gastric cancer.
Detailed Description
The result of treatment in relapsed and refractory gastric cancer is still not satisfactory. For the moment, the combination of 5-Fu and cisplatin is regularly used. Capecitabine and Oxaliplatin are new generation drugs of 5-Fu and cisplatin. The current study is to evaluate the efficacy and toxicity of this combination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Advanced gastric cancer, Response rate, Side effects, time to progression, overall survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combine Chemotherapy
Arm Type
Experimental
Arm Description
XELOX(Xeloda and oxaliplatin combination)
Intervention Type
Drug
Intervention Name(s)
Capecitabine and Oxaliplatin
Other Intervention Name(s)
XELOX(Xeloda and oxaliplatin combination)
Intervention Description
Capecitabine 1000mg/m2 Bid d1-14 Oxaliplatin 130mg/m2 d1 q3w
Primary Outcome Measure Information:
Title
Response Rate
Time Frame
2-6 months
Secondary Outcome Measure Information:
Title
time to progression and overall survival
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 70 years
Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma
ECOG performance status ≤1
Measurable diseases according to the RECIST
Relapse or refractory after the first-line chemotherapy
Sign ICF,normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).
Exclusion Criteria:
Relapse within 6 months after adjuvant chemotherapy which contained oxaliplatin
Have used any of drugs in the regimen in first-line chemotherapy
Pregnant or lactating women,serious uncontrolled diseases and intercurrent infection
The evidence of CNS metastasis
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Received other chemotherapy regimen after metastasis
Participated in other clinical trials.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer
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