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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hydroxychloroquine may help docetaxel work better and kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with hydroxychloroquine works in treating patients with metastatic prostate cancer.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	docetaxel
DRUG	hydroxychloroquine

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2008-11-06
• Last updated: 2023-08-14
• Results posted: 2013-11-25

Locations

7 sites across 1 country: United States