Spots Global Cancer Trial Database for Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer

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Trial Identification

Brief Title: Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer

Official Title: A Phase II Study of Docetaxel and Modulation of Autophagy With Hydroxychloroquine for Metastatic Hormone Refractory Prostate Cancer

Study ID: NCT00786682

Conditions

Prostate Cancer

Interventions

docetaxel

hydroxychloroquine

Study Description

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.