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Study of Oxaliplatin and Xeloda and Cetuximab as First Line Treatment for Metastatic or Unresectable Gastric or Gastroesophageal Junction Cancer

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results first posted: Jul 30, 2026 Primary endpoint revised · Trial status: Active, Not Recruiting to Completed · Study completion date changed from estimate of Dec 28, 2019 to Jun 19, 2020 · 1 morev19 Show 4 more changesShow less
    • Primary endpoint revised
    • Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Dec 28, 2019 to Jun 19, 2020
    • Secondary endpoints: 2 to 5

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date changed from estimate of Dec 28, 2018 to Feb 4, 2013 Completion date: Jun 28, 2019 to Dec 28, 2019v18 Show 1 more changeShow less
    • Completion date: Jun 28, 2019 to Dec 28, 2019
  3. Primary completion date: Dec 28, 2017 to Dec 28, 2018 Completion date: Jun 28, 2018 to Jun 28, 2019v17 Show 1 more changeShow less
    • Completion date: Jun 28, 2018 to Jun 28, 2019
  4. Primary completion date: Jun 2016 to Dec 28, 2017 Completion date: Jun 2017 to Jun 28, 2018 · Start date: Dec 2004 to Dec 28, 2004v16 Show 2 more changesShow less
    • Completion date: Jun 2017 to Jun 28, 2018
    • Start date: Dec 2004 to Dec 28, 2004
  5. Primary completion date: Jan 2015 to Jun 2016 Completion date: Dec 2015 to Jun 2017v15 Show 1 more changeShow less
    • Completion date: Dec 2015 to Jun 2017
Show 13 earlier versionsHide 13 earlier versions
  1. Primary completion date: Jan 2014 to Jan 2015 Completion date: Jan 2016 to Dec 2015v14 Show 1 more changeShow less
    • Completion date: Jan 2016 to Dec 2015
  2. Primary completion date: Jan 2013 to Jan 2014 Completion date: Jan 2015 to Jan 2016 · Study arms: 0 to 1v13 Show 2 more changesShow less
    • Completion date: Jan 2015 to Jan 2016
    • Study arms: 0 to 1
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 53 to confirmed 75 · Primary completion date: Dec 2012 to Jan 2013 · Completion date: Dec 2014 to Jan 2015 · 1 morev12 Show 4 more changesShow less
    • Enrollment target: estimated 53 to confirmed 75
    • Primary completion date: Dec 2012 to Jan 2013
    • Completion date: Dec 2014 to Jan 2015
    • Site details revised
  4. Primary completion date: Jan 2012 to Dec 2012 Completion date: Jan 2014 to Dec 2014v11 Show 1 more changeShow less
    • Completion date: Jan 2014 to Dec 2014
  5. Primary completion date: Jan 2010 to Jan 2012 Completion date: Jan 2014v10 Show 1 more changeShow less
    • Completion date: Jan 2014
  6. 2 versions Re-verified since Jul 24, 2009, no change to tracked fieldsv8-v9
  7. Primary completion date: Jun 2009 to Jan 2010v7
  8. Primary completion date: Jun 2009 Secondary endpoints: 3 to 2v6 Show 1 more changeShow less
    • Secondary endpoints: 3 to 2

    See this version in full on ClinicalTrials.gov ↗

  9. Collaborators: 2 to 3 Eligibility criteria shortened, about 3 words · Study title expanded, about 2 wordsv5 Show 2 more changesShow less
    • Eligibility criteria shortened, about 3 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  10. Eligibility criteria expanded, about 19 words Secondary endpoints revised (3) · Primary endpoint revisedv4 Show 2 more changesShow less
    • Secondary endpoints revised (3)
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  11. Re-verified, no change to tracked fieldsv3
  12. Eligibility criteria revisedv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is for people with advanced gastric or gastroesophageal cancer. This study is being done to find out how long it takes tumors to grow after patients take the drugs capecitabine, oxaliplatin and cetuximab. Capecitabine (also called Xeloda) is a drug that has been approved by the Food and Drug Administration (FDA). Capecitabine has been approved for treatment of cancer of the colon and rectum. Oxaliplatin is another drug approved by the FDA. Oxaliplatin is also approved for treatment of cancer of the colon and rectum. Cetuximab is also a drug approved by the FDA for the treatment of cancer of the colon and rectum, as well as cancer of the head and neck. Capecitabine, oxaliplatin and cetuximab are not approved for gastric or gastroesophageal cancer. They are considered experimental drugs for this study. The purpose of this study is to see how long it takes patients' tumors to progress when they are taking oxaliplatin and capecitabine. Another purpose is to see how many tumors respond to this drug combination. The investigators also want to see how long people live when taking these drugs. The side effects of this drug combination will also be evaluated. This study will also measure the levels of certain genes (the cell's blueprint) in tumors. These genes affect how peoples' bodies react to the cancer drugs. Genes will also be measured in the blood. The investigators want to see how these genes can predict response to these study drugs.
Trial Details
NCT Number NCT00183898
Lead Sponsor University of Southern California
Collaborators: Sanofi, Roche Global Development, Bristol-Myers Squibb
Conditions Gastric Cancer, Esophageal Cancer
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov