Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed
    • Primary completion date changed from estimate of Sep 30, 2026 to Apr 14, 2026
    • Eligibility criteria shortened, about 15 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. 2 versions Re-verified since Oct 24, 2025, no change to tracked fieldsv35-v36
  3. Study Identification, Study Statusv34
  4. Primary and study completion dates: Sep 30, 2024 to Sep 30, 2026
    • Collaborators shortened, about 3 words
    v33
  5. Study Identification, Study Status, Oversight, IPDSharingv32
Show 30 earlier versionsHide 30 earlier versions
  1. Re-verified, no change to tracked fieldsv31
  2. Primary and study completion dates: Sep 30, 2022 to Sep 30, 2024v30
  3. Re-verified, no change to tracked fieldsv29
  4. Primary completion date: Sep 30, 2021 to Sep 30, 2022v28
  5. Primary completion date: Sep 30, 2020 to Sep 30, 2021
    • Study completion date: Sep 30, 2020 to Sep 30, 2022
    v27
  6. Primary completion date: Sep 2019 to Sep 30, 2020
    • Study completion date: Sep 2020 to Sep 30, 2020
    • Start date: Sep 2006 to Sep 28, 2006
    v26
  7. Re-verified, no change to tracked fieldsv25
  8. Primary completion date: Sep 2018 to Sep 2019
    • Study completion date: Sep 2018 to Sep 2020
    v24
  9. Re-verified, no change to tracked fieldsv23
  10. Primary completion date: Sep 2017 to Sep 2018
    • Study completion date: Sep 2018
    • Secondary endpoints expanded, about 8 words
    • Primary endpoint revised
    v22
  11. Primary completion date: Sep 2016 to Sep 2017v21
  12. Primary completion date: Sep 2015 to Sep 2016
    • Study site revised
    v20
  13. Eligibility criteria expanded, about 1 wordv19
  14. Study Status, Study Description, Arms and Interventionsv18
  15. Primary completion date: Sep 2014 to Sep 2015v17
  16. 2 versions Re-verified since Dec 19, 2012, no change to tracked fieldsv15-v16
  17. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v14
  18. Re-verified, no change to tracked fieldsv13
  19. Primary completion date: Sep 2012 to Sep 2014v12
  20. Study description shortened, about 260 wordsv11
  21. Re-verified, no change to tracked fieldsv10
  22. Primary completion date: Sep 2011 to Sep 2012v9
  23. Primary completion date: Sep 2010 to Sep 2011v8
  24. Study site revisedv7
  25. Primary endpoint revisedv6
  26. Primary completion date: Sep 2009 to Sep 2010v5
  27. Eligibility criteria revised
    • Study description expanded, about 1 word
    v4
  28. Primary endpoint revisedv3 Show 5 more changesShow less
    • Primary completion date: Sep 2009
    • Study completion date: Sep 2008 to not stated
    • Secondary endpoints shortened, about 55 words
    • Study description shortened, about 25 words
    • Study title shortened, about 2 words
  29. Study completion date: Sep 2008
    • Eligibility criteria revised
    • Study arms: 0 to 1
    v2
  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.
The goal of this clinical research study is to find the highest tolerable dose of Gemzar® (gemcitabine) and Adriamycin® (doxorubicin) that can be given together with Velcade® (bortezomib) in patients with urothelial cancer or other solid tumors.
Trial Details
NCT Number NCT00479128
Lead Sponsor M.D. Anderson Cancer Center
Conditions
(from sponsor)		 Solid Tumor, Urethral Cancer
Related terms Ureteral Neoplasms, Urethral Neoplasms, Urinary Bladder Neoplasms
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov