A Phase II Study of Docetaxel and Modulation of Autophagy With Hydroxychloroquine for Metastatic Hormone Refractory Prostate Cancer
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.
Interventional
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
No
Mark Stein, MD
Principal Investigator
Cancer Institute of New Jersey
United States: Institutional Review Board
CDR0000617998
NCT00786682
December 2008
April 2012
Name | Location |
---|---|
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 |