OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Trial completed
    • Study completion moved earlier from Jun 30, 2026 to May 1, 2025
    v40
  2. Results first posted: Apr 15, 2026
    • Primary endpoint revised
    • Primary completion date changed from estimate of Jun 30, 2026 to May 1, 2025
    • Secondary endpoints: 1 to 2
    v39
  3. Primary and study completion dates: Jun 30, 2025 to Jun 30, 2026v38
  4. Re-verified, no change to tracked fieldsv37
  5. Primary and study completion dates: Dec 31, 2024 to Jun 30, 2025v36
Show 34 earlier versionsHide 34 earlier versions
  1. 2 versions Re-verified since Sep 30, 2023, no change to tracked fieldsv34-v35
  2. Primary and study completion dates: Sep 30, 2023 to Dec 31, 2024v33
  3. Primary completion date: Feb 2007 to Sep 30, 2023v32 Show 4 more changesShow less
    • Study completion date: Sep 2023 to Sep 30, 2023
    • Secondary endpoint revised
    • Study site revised
    • Collaborators: 2 to 1
  4. Primary completion date changed from estimate of Sep 1, 2021 to Feb 2007
    • Study completion date: Sep 1, 2021 to Sep 2023
    v31
  5. Primary and study completion dates: Sep 1, 2020 to Sep 1, 2021v30
  6. Primary and study completion dates: Jan 2019 to Sep 1, 2020
    • Start date: Jan 2004 to Jan 28, 2004
    v29
  7. Study description expanded, about 19 wordsv28
  8. 2 versions Re-verified since Aug 8, 2017, no change to tracked fieldsv26-v27
  9. Primary and study completion dates pushed to Jan 2019v25
  10. Primary completion date changed from estimate of Jan 2018 to Feb 2007
    • Study completion date: Feb 2017
    v24
  11. Primary completion date: Jan 2017 to Jan 2018v23
  12. Re-verified, no change to tracked fieldsv22
  13. Primary completion date: Jan 2016 to Jan 2017v21
  14. Primary completion date: Jan 2015 to Jan 2016
    • Primary endpoint revised
    • Secondary endpoint revised
    • Study site revised
    v20
  15. Primary completion date: Jan 2014 to Jan 2015v19
  16. 2 versions Re-verified since Mar 13, 2012, no change to tracked fieldsv17-v18
  17. Primary completion date: Jan 2013 to Jan 2014v16
  18. Primary completion date: Jan 2012 to Jan 2013v15
  19. Re-verified, no change to tracked fieldsv14
  20. Primary completion date: Jan 2011 to Jan 2012v13
  21. Study site revisedv12
  22. Primary completion date: Dec 2009 to Jan 2011v11
  23. Primary completion date: Sep 2008 to Dec 2009v10 Show 4 more changesShow less
    • Primary endpoint revised
    • Study completion date: Sep 2008 to not stated
    • Secondary endpoints: 2 to 1
    • Study description expanded, about 11 words
  24. Eligibility criteria expanded, about 37 words
    • Secondary endpoints: 1 to 2
    • Study description expanded, about 403 words
    v9
  25. Primary and study completion dates: Sep 2008
    • Study arms: 0 to 1
    v8
  26. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    • Collaborators expanded, about 4 words
    v7
  27. 2 versions Re-verified since Jun 7, 2006, no change to tracked fieldsv5-v6
  28. Trial status: Suspended to Recruiting
    • Site details revised
    v4
  29. Re-verified, no change to tracked fieldsv3
  30. Trial status: Recruiting to Suspended
    • Site details revised
    v2
  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.
The goal of this clinical research study is to learn if giving the new drug, Tarceva® (OSI-774), in combination with Platinol® (cisplatin) and Taxotere® (docetaxel) is effective in the treatment of metastatic or recurrent head and neck cancer. The safety of this treatment will also be studied.
Trial Details
NCT Number NCT00076310
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Genentech, Inc.
Conditions
(from sponsor)		 Head and Neck Cancer
Related terms Head and Neck Neoplasms, Neoplasms, Squamous Cell, Squamous Cell Carcinoma of Head and Neck
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov