A Phase II Study of Docetaxel and Modulation of Autophagy With Hydroxychloroquine for Metastatic Hormone Refractory Prostate Cancer
- 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.
- 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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response rate
Treatment start date to date of best of response
Mark Stein, MD
Cancer Institute of New Jersey
United States: Institutional Review Board
|Overlook Hospital||Summit, New Jersey 07902-0220|
|Carol G. Simon Cancer Center at Morristown Memorial Hospital||Morristown, New Jersey 07962|
|Cancer Institute of New Jersey at Hamilton||Hamilton, New Jersey 08690|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|
|Mountainside Hospital||Montclair, New Jersey 07042|