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

Last updated: November 1, 2016
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Gastric Cancer

Digestive System Neoplasms

Stomach Cancer

Treatment

N/A

Clinical Study ID

NCT02563054
ML17032
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults 18 to 75 years of age

  • Advanced and/or metastatic gastric cancer with at least 1 measurable lesion

Exclusion

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 ofthe skin or cured in-situ cancer of the uterine cervix

  • Radiation therapy or major surgery within 4 weeks of study drug

  • Previous chemotherapy

Study Design

Total Participants: 316
Study Start date:
April 01, 2003
Estimated Completion Date:
August 31, 2010

Connect with a study center

  • Buenos Aires, C1264AAA
    Argentina

    Site Not Available

  • Rosario, S2000PBJ
    Argentina

    Site Not Available

  • Tegucigalpa,
    Belize

    Site Not Available

  • Barretos, 14780-400
    Brazil

    Site Not Available

  • Curitiba, 80060-150
    Brazil

    Site Not Available

  • Florianopolis, 88034-000
    Brazil

    Site Not Available

  • Fortaleza, 60741-420
    Brazil

    Site Not Available

  • Porto Alegre, 90020-090
    Brazil

    Site Not Available

  • Sao Paulo, 05403-010
    Brazil

    Site Not Available

  • Sorocaba, 18035-300
    Brazil

    Site Not Available

  • Beijing, 100036
    China

    Site Not Available

  • Guangdong, 510060
    China

    Site Not Available

  • Hubei, 430030
    China

    Site Not Available

  • Jiangsu, 210009
    China

    Site Not Available

  • Jiangxi, 330000
    China

    Site Not Available

  • Shandong, 250117
    China

    Site Not Available

  • Shanghai, 200092
    China

    Site Not Available

  • Suzhou, 215006
    China

    Site Not Available

  • Tianjin, 300060
    China

    Site Not Available

  • Bogota,
    Colombia

    Site Not Available

  • Guatemala City, 01015
    Guatemala

    Site Not Available

  • Hong Kong,
    Hong Kong

    Site Not Available

  • Seoul, 138-736
    Korea, Republic of

    Site Not Available

  • Kuala Lumpur, 56000
    Malaysia

    Site Not Available

  • Merida, 97070
    Mexico

    Site Not Available

  • Mexico City, 14080
    Mexico

    Site Not Available

  • Mexico Df, 06726
    Mexico

    Site Not Available

  • Panama City, 83-0669
    Panama

    Site Not Available

  • Callao,
    Peru

    Site Not Available

  • Lima, 13
    Peru

    Site Not Available

  • Kazan, 420029
    Russian Federation

    Site Not Available

  • Moscow, 115478
    Russian Federation

    Site Not Available

  • St Petersburg, 197758
    Russian Federation

    Site Not Available

  • UFA, 450054
    Russian Federation

    Site Not Available

  • Montevideo, 11600
    Uruguay

    Site Not Available

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