A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus 5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at least 6 weeks and continued up to disease progression, and the target sample size is 300 individuals.

Official Title
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An Open-Label Randomized International Multi-Center Phase III Study of Capecitabine (Xeloda) in Combination With Cisplatin Versus FU/Cisplatin in Patients With Advanced and/or Metastatic Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: 5-Fluorouracil
* Drug: Capecitabine
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 to 75 years of age Advanced and/or metastatic gastric cancer with at least 1 measurable lesion Exclusion Criteria: Uncontrolled infection Evidence of central nervous system (CNS) metastases History of other malignancy within the last 5 years, except cured basal cell cancer of the skin or cured in-situ cancer of the uterine cervix Radiation therapy or major surgery within 4 weeks of study drug Previous chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5-Fluorouracil + Cisplatin<br>Participants will receive 5-FU in combination with cisplatin upto disease progression. | Drug: 5-Fluorouracil<br>* Participants will receive 5-FU, 800 milligrams per meter-squared (mg/m^2) per day via IV infusion during Days 1 to 5 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.<br>Drug: Cisplatin<br>* Participants will receive cisplastin, 80 mg/m^2 via IV infusion on Day 1 of each 3-week cycle, for a total of 6 cycles or upto disease progression in combination with either capecitabine or 5-FU.<br>|
| Experimental: Capecitabine + Cisplatin<br>Participants will receive capecitabine in combination with cisplatin upto disease progression. | Drug: Capecitabine<br>* Participants will receive oral capecitabine, 1000 mg/m^2 twice daily on Days 1 to 14 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.<br>Drug: Cisplatin<br>* Participants will receive cisplastin, 80 mg/m^2 via IV infusion on Day 1 of each 3-week cycle, for a total of 6 cycles or upto disease progression in combination with either capecitabine or 5-FU.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression |  | Up to approximately 7.3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumor response rate |  | Up to approximately 7.3 years | 
| Overall survival |  | Up to approximately 7.3 years | 
| Duration of response |  | Up to approximately 7.3 years | 
| Time to response |  | Up to approximately 7.3 years | 
| Incidence of adverse events |  | Up to approximately 7.3 years |