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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

316

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1270AAE
      • Buenos Aires, Argentina, C1264AAA
      • Rosario, Argentina, S2000PBJ
  • Belize
      • Tegucigalpa, Belize
  • Brazil
      • Barretos, Brazil, 14780-400
      • Curitiba, Brazil, 80060-150
      • Florianopolis, Brazil, 88034-000
      • Fortaleza, Brazil, 60741-420
      • Porto Alegre, Brazil, 90020-090
      • Sao Paulo, Brazil, 05403-010
      • Sorocaba, Brazil, 18035-300
  • China
      • Beijing, China, 100021
      • Beijing, China, 100036
      • Guangdong, China, 510515
      • Guangdong, China, 510060
      • Hubei, China, 430030
      • Jiangsu, China, 210009
      • Jiangxi, China, 330000
      • Shandong, China, 250117
      • Shanghai, China, 200433
      • Shanghai, China, 200003
      • Shanghai, China, 200092
      • Suzhou, China, 215006
      • Tianjin, China, 300060
  • Colombia
      • Bogota, Colombia
  • Guatemala
      • Guatemala City, Guatemala, 01015
  • Hong Kong
      • Hong Kong, Hong Kong
      • Hong Kong, Hong Kong, 852
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 135-720
      • Seoul, Korea, Republic of, 135-170
      • Seoul, Korea, Republic of, 405-760
  • Malaysia
      • Kuala Lumpur, Malaysia, 56000
  • Mexico
      • Merida, Mexico, 97070
      • Mexico City, Mexico, 14000
      • Mexico City, Mexico, 14080
      • Mexico Df, Mexico, 06726
  • Panama
      • Panama City, Panama, 83-0669
  • Peru
      • Callao, Peru
      • Lima, Peru, 13
  • Russian Federation
      • Kazan, Russian Federation, 420029
      • Moscow, Russian Federation, 115478
      • St Petersburg, Russian Federation, 197758
      • UFA, Russian Federation, 450054
  • Uruguay
      • Montevideo, Uruguay, 11600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 5-Fluorouracil + Cisplatin
Participants will receive 5-FU in combination with cisplatin upto disease progression.
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.
Experimental: Capecitabine + Cisplatin
Participants will receive capecitabine in combination with cisplatin 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to disease progression
Time Frame: Up to approximately 7.3 years
Up to approximately 7.3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML17032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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