A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.
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
1 other identifier
interventional
45
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 gastric-cancer
Started Mar 2007
Typical duration for phase_2 gastric-cancer
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2007
CompletedFirst Posted
Study publicly available on registry
February 19, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedNovember 2, 2016
November 1, 2016
3.7 years
February 16, 2007
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response rate
Event driven
Secondary Outcomes (2)
Time to disease progression, overall survival, duration of response, time to response.
Event driven
AEs, laboratory parameters.
Throughout study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Unknown Facility
Chai Yi, 613, Taiwan
Unknown Facility
Chai Yi, 622, Taiwan
Unknown Facility
Kaohsiung City, 807, Taiwan
Unknown Facility
Keelung, 204, Taiwan
Unknown Facility
Taichung, 404, Taiwan
Unknown Facility
Taichung, 407, Taiwan
Unknown Facility
Tainan, 704, Taiwan
Unknown Facility
Tainan, 710, Taiwan
Unknown Facility
Taipei, 00112, Taiwan
Unknown Facility
Taipei, 106, Taiwan
Unknown Facility
Taipei, 110, Taiwan
Unknown Facility
Taoyuan District, 333, Taiwan
Unknown Facility
Yilan, 265, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2007
First Posted
February 19, 2007
Study Start
March 1, 2007
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
November 2, 2016
Record last verified: 2016-11