deltatrials
Terminated PHASE2 INTERVENTIONAL 1-arm NCT00786682

Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer

A Phase II Study of Docetaxel and Modulation of Autophagy With Hydroxychloroquine for Metastatic Hormone Refractory Prostate Cancer

Sponsor: National Cancer Institute (NCI)

Conditions Prostate Cancer
Interventions docetaxel hydroxychloroquine
Updated 9 times since 2017 Last updated: Jul 31, 2023 Started: Dec 31, 2008 Primary completion: Oct 31, 2012 Completion: Oct 31, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Lack of improved efficacy compared to historical controls, competing studies

A PHASE2 clinical study on Prostate Cancer, this trial is terminated or withdrawn. The trial is conducted by National Cancer Institute (NCI) and has accumulated 9 data snapshots since 2008. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

OBJECTIVES: Primary * To assess the antitumor activity, in terms of tumor response rate, of docetaxel in combination with hydroxychloroquine in patients with metastatic, hormone-refractory, chemotherapy-naive prostate cancer. Secondary * To measure time to disease progression and overall survival. * To determine the feasibility and safety of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral hydroxychloroquine twice daily on days 1-21 and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days (up to 6 courses with docetaxel) in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

Primary

* To assess the antitumor activity, in terms of tumor response rate, of docetaxel in combination with hydroxychloroquine in patients with metastatic, hormone-refractory, chemotherapy-naive prostate cancer.

Secondary

* To measure time to disease progression and overall survival. * To determine the feasibility and safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral hydroxychloroquine twice daily on days 1-21 and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days (up to 6 courses with docetaxel) in the absence of disease progression or unacceptable toxicity.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotTerminated~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotTerminated~Jan 2023 – ~Sep 2023 · 8 months · monthly snapshotTerminated~Sep 2023 – ~Jul 2024 · 10 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated

Change History

9 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. Sep 2023 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Jan 2023 — Sep 2023 [monthly]

    Terminated PHASE2

  5. Dec 2022 — Jan 2023 [monthly]

    Terminated PHASE2

▶ Show 4 earlier versions

  1. Jan 2021 — Dec 2022 [monthly]

    Terminated PHASE2

  2. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE2

  3. Feb 2017 — Jun 2018 [monthly]

    Terminated PHASE2

  4. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE2

    First recorded

Dec 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
  • University of Medicine and Dentistry of New Jersey
Data source: Rutgers, The State University of New Jersey

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

Study Locations