Gastric Cancer
Conditions
Brief summary
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.
Interventions
DRUG5-Fluorouracil
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.
DRUGCapecitabine
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.
DRUGCisplatin
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to disease progression | Up to approximately 7.3 years |
Secondary
| Measure | 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 |
Countries
Argentina, Belize, Brazil, China, Colombia, Guatemala, Hong Kong, Malaysia, Mexico, Panama, Peru, Russia, South Korea, Uruguay
Outcome results
None listed