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

An open, randomized, international, multicenter, phase III study of Capecitabine (Xeloda®) in combination with cisplatin versus 5-FU / cisplatin in patients with advanced and / or metastatic gastric cancer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-018-04
Enrollment
13
Registered
2004-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Active comparator: 5-fluorouracil + cisplatin Type of group
Drug: 5-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. Drug: Cisplatin 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. Group name:Capecitabine + Cispla
Drug: Capecitabine 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. Drug: Cisplatin 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

PRODUCTOS ROCHE Q.F.S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults 18 to 75 years of age Advanced and/or metastatic gastric cancer with at least 1 measurable lesion

Exclusion criteria

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

MeasureTime frame
Outcome name:Tiempo hasta la progresion de la enfermedad Measure:Time to disease progression Timepoints:Up to approximately 7.3 years—

Secondary

MeasureTime frame
Outcome name:Overall survival Measure:Overall survival Timepoints:Up to approximately 7.3 years—

Countries

Argentina, Belize, Brazil, China, Colombia, Guatemala, Korea South, Malasya, Mexico, Panama, Peru, Russian Federation, Uruguay

Outcome results

None listed

Source: REPEC (via WHO ICTRP)