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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States
Mountainside Hospital
Montclair, New Jersey, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
Tumor Response Rate - Primary Endpoint is a 50% Decline in PSA or Normalization of PSA.
We will use a two-stage optimal Simon's design with a 5% significance level and 80% power to detect an increase in response rate from 50% to 70%. The first stage will enroll 15 patients. If there are 8 or fewer responses among these 15 patients, we will consider the combination therapy to not be worthy of further study, and stop the trial. If we find 9 or more responses, we will proceed to the second stage, and accrual continues for a total of 43 patients. If we see 26 or fewer responses out of 43, then no further investigation of the drug is warranted. If we see 27 or more responses out of 43, then further investigation of the drug will be considered. The "expected" sample size of the trial is 23.5 with the null response rate of 50%.
Time frame: 4 years
Time to Disease Progression
Time frame: 10 years
Overall Survival
Time frame: 10 years
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New Brunswick, New Jersey, United States
St. Peters University Hospital
New Brunswick, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States