deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT00821327

Gemzar, Cisp, Sunitinib Urothelial Ca

Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients With Advanced/Metastatic Urothelial Carcinoma

Sponsor: Pfizer

Updated 8 times since 2017 Last updated: Sep 15, 2016 Started: Aug 31, 2008 Primary completion: Aug 31, 2012 Completion: Aug 31, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00821327, this PHASE2 trial focuses on Urothelial Cancer and remains completed. Sponsored by Pfizer, it has been updated 8 times since 2008, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

Given the strong preclinical rationale for targeting angiogenesis in urothelial carcinoma (UC), the evidence supporting co-targeting of VEGFR2 and PDGF, the safety and efficacy of single-agent sunitinib in patients with UC, and preclinical evidence of synergy with the combination of sunitinib and cisplatin, the evaluation of sunitinib in combination with gemcitabine plus cisplatin in previously untreated patients with metastatic UC is warranted.

Given the strong preclinical rationale for targeting angiogenesis in urothelial carcinoma (UC), the evidence supporting co-targeting of VEGFR2 and PDGF, the safety and efficacy of single-agent sunitinib in patients with UC, and preclinical evidence of synergy with the combination of sunitinib and cisplatin, the evaluation of sunitinib in combination with gemcitabine plus cisplatin in previously untreated patients with metastatic UC is warranted.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2025 — Present [monthly]

    Completed PHASE2

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  5. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Aug 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Pfizer
  • US Oncology Research
Data source: US Oncology Research

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