deltatrials
Active Not Recruiting PHASE2 INTERVENTIONAL 1-arm NCT00082706

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

Phase II Trial of 5-FU, Leucovorin, Gemcitabine, and Cisplatin for Adenocarcinomas of the Urothelial Tract and Urachal Remnant

Sponsor: M.D. Anderson Cancer Center

Conditions Bladder Cancer Urachal Cancer Urethral Cancer
Interventions 5-Fluorouracil (5-FU) Cisplatin Gemcitabine Leucovorin
Updated 19 times since 2017 Last updated: Sep 5, 2025 Started: Apr 23, 2003 Primary completion: Dec 31, 2025 Completion: Dec 31, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00082706, this PHASE2 trial focuses on Bladder Cancer and Urachal Cancer and remains ongoing. Sponsored by M.D. Anderson Cancer Center, it has been updated 19 times since 2003, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Dec 2017 · 10 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshot~Dec 2018 – ~Oct 2019 · 10 months · monthly snapshot~Oct 2019 – ~Mar 2020 · 5 months · monthly snapshot~Mar 2020 – ~Jan 2021 · 10 months · monthly snapshot~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshot~Jun 2021 – ~May 2022 · 11 months · monthly snapshot~May 2022 – ~Nov 2022 · 6 months · monthly snapshot~Nov 2022 – ~May 2023 · 6 months · monthly snapshot~May 2023 – ~Nov 2023 · 6 months · monthly snapshot~Nov 2023 – ~Jun 2024 · 7 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~May 2025 · 7 months · monthly snapshot~May 2025 – ~Oct 2025 · 5 months · monthly snapshot~Oct 2025 – present · 10 months · monthly snapshot

Change History

19 versions recorded

  1. Oct 2025 — Present [monthly]

    Active Not Recruiting PHASE2

  2. May 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE2

  3. Oct 2024 — May 2025 [monthly]

    Active Not Recruiting PHASE2

  4. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2

▶ Show 14 earlier versions

  1. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2

  2. Nov 2023 — Jun 2024 [monthly]

    Active Not Recruiting PHASE2

  3. May 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE2

  4. Nov 2022 — May 2023 [monthly]

    Active Not Recruiting PHASE2

  5. May 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE2

  6. Jun 2021 — May 2022 [monthly]

    Active Not Recruiting PHASE2

  7. Jan 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE2

  8. Mar 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  9. Oct 2019 — Mar 2020 [monthly]

    Active Not Recruiting PHASE2

  10. Dec 2018 — Oct 2019 [monthly]

    Active Not Recruiting PHASE2

  11. Jun 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE2

  12. Dec 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

  13. Feb 2017 — Dec 2017 [monthly]

    Active Not Recruiting PHASE2

  14. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Apr 2003

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: M.D. Anderson Cancer Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations