Conditions: Prostate Cancer
Keywords: stage IV prostate cancer recurrent prostate cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 11
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle

Drug: hydroxychloroquine 200 mg twice daily

A cycle is defined as an interval of 21 days.

Interventions: intervention 1: docetaxel intervention 2: hydroxychloroquine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: