Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant

StatusActive, Not Recruiting
PhasePhase 2
Started

Record status This record was last updated September 9, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

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Record History

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  1. 2 versions Re-verified since Mar 31, 2025, no change to tracked fieldsv48-v49
  2. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025v47
  3. Re-verified, no change to tracked fieldsv46
  4. Primary and study completion dates: Dec 31, 2023 to Dec 31, 2024v45
  5. Re-verified, no change to tracked fieldsv44
Show 42 earlier versionsHide 42 earlier versions
  1. Primary and study completion dates: Dec 15, 2022 to Dec 31, 2023
    • Start date: Apr 2003 to Apr 23, 2003
    v43
  2. Re-verified, no change to tracked fieldsv42
  3. Primary completion date: Dec 15, 2021 to Dec 15, 2022v41
  4. Primary completion date: Jul 30, 2020 to Dec 15, 2021
    • Study completion date: Jul 30, 2020 to Dec 15, 2022
    v40
  5. Primary and study completion dates: Dec 2019 to Jul 30, 2020v39
  6. Primary and study completion dates: Apr 2019 to Dec 2019v38
  7. Re-verified, no change to tracked fieldsv37
  8. Primary completion date: Feb 2018 to Apr 2019
    • Study completion date: Apr 2019
    v36
  9. Primary completion date: Feb 2017 to Feb 2018v35
  10. Study completion date: Feb 2017 to not statedv34
  11. Primary and study completion dates: Feb 2015 to Feb 2017
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study site revised
    v33
  12. Primary and study completion dates: Feb 2014 to Feb 2015v32
  13. Primary and study completion dates: Feb 2013 to Feb 2014v31
  14. Primary and study completion dates: Feb 2012 to Feb 2013v30
  15. Re-verified, no change to tracked fieldsv29
  16. Primary and study completion dates: Feb 2011 to Feb 2012v28
  17. 2 versions Re-verified since Aug 20, 2010, no change to tracked fieldsv26-v27
  18. Primary endpoints: 2 to 1v25 Show 8 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Feb 2011
    • Interventions: cisplatin (Drug), fluorouracil (Drug), gemcitabine hydrochloride (Drug), leucovorin calcium (Drug) to 5-Fluorouracil (5-FU) (Drug), Cisplatin (Drug), Gemcitabine (Drug), Leucovorin (Drug)
    • Eligibility criteria expanded, about 260 words
    • Secondary endpoint revised
    • Site details revised
    • Study arms: 0 to 1
    • Study description expanded, about 2 words
  19. 2 versions Re-verified since Jul 23, 2008, no change to tracked fieldsv23-v24
  20. Interventions: chemotherapy (Procedure), cisplatin (Drug), fluorouracil (Drug), gemcitabine hydrochloride (Drug), leucovorin calcium (Drug) to cisplatin (Drug), fluorouracil (Drug), gemcitabine hydrochloride (Drug), leucovorin calcium (Drug)v22
  21. Re-verified, no change to tracked fieldsv21
  22. Start date: Apr 2003v20
  23. Re-verified, no change to tracked fieldsv19
  24. Study Status, Contacts/Locationsv18
  25. Study Status, Outcome Measuresv17
  26. Re-verified, no change to tracked fieldsv16
  27. Study Status, Eligibilityv15
  28. 3 versions Re-verified since Jan 5, 2007, no change to tracked fieldsv12-v14
  29. Enrollment target: 46v11
  30. 3 versions Re-verified since May 23, 2006, no change to tracked fieldsv8-v10
  31. Site contact updatedv7
  32. Re-verified, no change to tracked fieldsv6
  33. Site details revisedv5
  34. Interventions: chemotherapy (Procedure), cisplatin (Drug), fluorouracil (Drug), gemcitabine (Drug), leucovorin calcium (Drug) to chemotherapy (Procedure), cisplatin (Drug), fluorouracil (Drug), gemcitabine hydrochloride (Drug), leucovorin calcium (Drug)v4
  35. 2 versions Re-verified since Jul 8, 2005, no change to tracked fieldsv2-v3
  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.
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin, gemcitabine, and cisplatin works in treating patients with metastatic or unresectable adenocarcinoma of the urothelium or urachal remnant (part of the bladder).
Trial Details
NCT Number NCT00082706
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Bladder Cancer, Urethral Cancer, Urachal Cancer
Related terms Urachal cancer, Urethral Neoplasms, Urinary Bladder Neoplasms
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov