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

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Notable Results first posted: Jul 30, 2026v19 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
  2. Minor Primary completion date changed from estimate of Dec 28, 2018 to Feb 4, 2013
    • Study completion date: Jun 28, 2019 to Dec 28, 2019
    v18
  3. Notable Primary completion date: Dec 28, 2017 to Dec 28, 2018
    • Study completion date: Jun 28, 2018 to Jun 28, 2019
    v17
  4. Notable Primary completion date: Jun 2016 to Dec 28, 2017
    • Study completion date: Jun 2017 to Jun 28, 2018
    • Start date: Dec 2004 to Dec 28, 2004
    v16
  5. Notable Primary completion date: Jan 2015 to Jun 2016
    • Study completion date: Dec 2015 to Jun 2017
    v15
Show 13 earlier versionsHide 13 earlier versions
  1. Notable Primary completion date: Jan 2014 to Jan 2015
    • Study completion date: Jan 2016 to Dec 2015
    v14
  2. Notable Primary completion date: Jan 2013 to Jan 2014
    • Study completion date: Jan 2015 to Jan 2016
    • Study arms: 0 to 1
    v13
  3. Minor Trial status: Recruiting to Active, Not Recruitingv12 Show 4 more changesShow less
    • Enrollment target: estimated 53 to confirmed 75
    • Primary completion date: Dec 2012 to Jan 2013
    • Study completion date: Dec 2014 to Jan 2015
    • Site details revised
  4. Notable Primary completion date: Jan 2012 to Dec 2012
    • Study completion date: Jan 2014 to Dec 2014
    v11
  5. Notable Primary completion date: Jan 2010 to Jan 2012
    • Study completion date: Jan 2014
    v10
  6. 2 versions Re-verified since Jul 24, 2009, no change to tracked fieldsv8-v9
  7. Notable Primary completion date: Jun 2009 to Jan 2010v7
  8. Minor Primary completion date: Jun 2009
    • Secondary endpoints: 3 to 2
    v6
  9. Minor Collaborators: 2 to 3
    • Eligibility criteria shortened, about 3 words
    • Study title expanded, about 2 words
    v5
  10. Minor Eligibility criteria expanded, about 19 words
    • Secondary endpoints revised (3)
    • Primary endpoint revised
    v4
  11. Re-verified, no change to tracked fieldsv3
  12. Minor Eligibility criteria revisedv2
  1. Study First Submitted
  • 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
(from sponsor)
Gastric Cancer, Esophageal Cancer
Related terms Esophageal Neoplasms, Stomach Neoplasms
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov