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

Phase 3

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: Capecitabine; Drug: 5-Fluorouracil; Drug: Cisplatin

• Registration Number: NCT02563054
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-29
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capecitabine + Cisplatin	Capecitabine	Participants will receive capecitabine in combination with cisplatin upto disease progression.
Capecitabine + Cisplatin	Cisplatin	Participants will receive capecitabine in combination with cisplatin upto disease progression.
5-Fluorouracil + Cisplatin	Cisplatin	Participants will receive 5-FU in combination with cisplatin upto disease progression.
5-Fluorouracil + Cisplatin	5-Fluorouracil	Participants will receive 5-FU in combination with cisplatin upto disease progression.

Primary Outcome Measures

Name	Time	Method
Time to disease progression	Up to approximately 7.3 years

Secondary Outcome Measures

Name	Time	Method
Objective tumor response rate	Up to approximately 7.3 years
Time to response	Up to approximately 7.3 years
Duration of response	Up to approximately 7.3 years
Overall survival	Up to approximately 7.3 years
Incidence of adverse events	Up to approximately 7.3 years