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Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv34
  2. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026v33
  3. 3 versions Re-verified since Dec 3, 2024, no change to tracked fieldsv30-v32
  4. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025v29
  5. Re-verified, no change to tracked fieldsv28
Show 26 earlier versionsHide 26 earlier versions
  1. Primary and study completion dates: May 31, 2023 to Dec 31, 2024v27
  2. Re-verified, no change to tracked fieldsv26
  3. Primary and study completion dates: May 2021 to May 31, 2023
    • Enrollment target: estimated 42 to confirmed 48
    v25
  4. Primary completion date: May 2020 to May 2021v24
  5. Primary completion date: Apr 30, 2019 to May 2020
    • Study completion date: Apr 30, 2019 to May 2021
    v23
  6. Primary endpoints: 1 to 4v22 Show 7 more changesShow less
    • Primary and study completion dates: Apr 2019 to Apr 30, 2019
    • Start date: Apr 2007 to Apr 25, 2007
    • Eligibility criteria expanded, about 58 words
    • Study description shortened, about 623 words
    • Study site revised
    • Collaborator revised
    • Study title expanded, about 8 words
  7. Re-verified, no change to tracked fieldsv21
  8. Study completion date: Apr 2019v20
  9. Primary completion date: Apr 2017 to Apr 2019v19
  10. Primary completion date: Apr 2016 to Apr 2017
    • Study description expanded, about 272 words
    v18
  11. Enrollment target: 40 to 42
    • Study description shortened, about 259 words
    v17
  12. Primary completion date: Apr 2015 to Apr 2016
    • Primary endpoint revised
    • Study site revised
    v16
  13. Primary completion date: Apr 2014 to Apr 2015v15
  14. Primary completion date: Apr 2013 to Apr 2014v14
  15. Enrollment target: 43 to 40v13
  16. Primary completion date: Apr 2012 to Apr 2013v12
  17. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v11
  18. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v10
  19. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v9
  20. Primary completion date: Apr 2011 to Apr 2012
    • Study description shortened, about 139 words
    v8
  21. Study site revisedv7
  22. Primary completion date: Jul 2010 to Apr 2011
    • Study description shortened, about 10 words
    v6
  23. Eligibility criteria expanded, about 18 words
    • Study description shortened, about 18 words
    v5
  24. Primary completion date: Jul 2009 to Jul 2010v4 Show 4 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints shortened, about 7 words
    • Study description expanded, about 42 words
  25. Primary completion date: Jul 2008 to Jul 2009v3 Show 4 more changesShow less
    • Primary endpoint revised
    • Study completion date: Jul 2008 to not stated
    • Secondary endpoint revised
    • Study description shortened, about 50 words
  26. Primary and study completion dates: Jul 2008v2 Show 5 more changesShow less
    • Interventions: Carboplatin (Drug), Paclitaxel (Drug), Sorafenib (BAY 43-9006) (Drug) to Carboplatin (Drug), Paclitaxel (Drug), Sorafenib (Drug)
    • Eligibility criteria expanded, about 9 words
    • Study description shortened, about 9 words
    • Study arms: 0 to 1
    • Study title shortened, about 5 words
  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 phase II trial studies how well sorafenib works with carboplatin and paclitaxel in treating participants with head and neck squamous cell cancer that has spread to other parts of the body or that has come back. Drugs used in chemotherapy, such as sorafenib, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Trial Details
NCT Number NCT00494182
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Squamous Cell Carcinoma of the Hypopharynx, Metastatic Squamous Cell Carcinoma of the Larynx, Metastatic Squamous Cell Carcinoma of the Oral Cavity, Metastatic Squamous Cell Carcinoma of the Oropharynx, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma +2 more
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov