Back to resultsA Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Oxaliplatin
capecitabine [Xeloda]
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- gastric cancer with unresectable locally advanced and/or metastatic disease;
- >=1 measurable lesion;
- ambulatory, with ECOG Performance Status >=1.
Exclusion Criteria:
- previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to enrollment);
- clinically significant cardiac disease or myocardial infarction within last 12 months;
- CNS metastases;
- history of other malignancy within last 5 years, except for cured basal cell cancer of the skin, or in situ cancer of the cervix.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Overall response rate
Secondary Outcome Measures
Time to disease progression, overall survival, duration of response, time to response.
AEs, laboratory parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00436241
Brief Title
A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.
Official Title
A Open Label Study of the Effect of First-line Therapy With Xeloda in Combination With Oxaliplatin on Overall Response Rate in Patients With Locally Advanced and/or Metastatic Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This single arm study will assess the efficacy and safety of Xeloda in combination with oxaliplatin as first-line chemotherapy in patients with advanced and/or metastatic gastric cancer who have had no prior chemotherapy for advanced or metastatic disease. Eligible patients will receive Xeloda 1000mg/m2 po twice daily, D1-D10 every 2 weeks (10 days treatment followed by 4 days rest period) plus oxaliplatin 85 mg/m2/day iv, D1 every 2 weeks. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
85mg/m2 iv on day 1 of each 2 week cycle
Intervention Type
Drug
Intervention Name(s)
capecitabine [Xeloda]
Intervention Description
1000mg/m2 po bid on days 1-10 of each 2 week cycle
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
Event driven
Secondary Outcome Measure Information:
Title
Time to disease progression, overall survival, duration of response, time to response.
Time Frame
Event driven
Title
AEs, laboratory parameters.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
gastric cancer with unresectable locally advanced and/or metastatic disease;
>=1 measurable lesion;
ambulatory, with ECOG Performance Status >=1.
Exclusion Criteria:
previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to enrollment);
clinically significant cardiac disease or myocardial infarction within last 12 months;
CNS metastases;
history of other malignancy within last 5 years, except for cured basal cell cancer of the skin, or in situ cancer of the cervix.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Chai Yi
ZIP/Postal Code
613
Country
Taiwan
City
Chai Yi
ZIP/Postal Code
622
Country
Taiwan
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
City
Keelung
ZIP/Postal Code
204
Country
Taiwan
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
City
Taipei
ZIP/Postal Code
106
Country
Taiwan
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
City
Yilan
ZIP/Postal Code
265
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.
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