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| Sponsor: | University of Medicine and Dentistry New Jersey |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00786682 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: docetaxel Drug: hydroxychloroquine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Docetaxel and Modulation of Autophagy With Hydroxychloroquine for Metastatic Hormone Refractory Prostate Cancer |
| Estimated Enrollment: | 43 |
| Study Start Date: | December 2008 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
PATIENT CHARACTERISTICS:
No history or symptoms of cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
No current hydroxychloroquine for treatment or prophylaxis
Contacts and Locations| United States, New Jersey | |
| Cancer Institute of New Jersey at Hamilton | |
| Hamilton, New Jersey, United States, 08690 | |
| Mountainside Hospital | |
| Montclair, New Jersey, United States, 07042 | |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | |
| Morristown, New Jersey, United States, 07962 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Overlook Hospital | |
| Summit, New Jersey, United States, 07901 | |
| Principal Investigator: | Mark Stein, MD | Cancer Institute of New Jersey |
More Information
| Responsible Party: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00786682 History of Changes |
| Other Study ID Numbers: | CDR0000617998, P30CA072720, CINJ-080805, 0220080244 |
| Study First Received: | November 5, 2008 |
| Last Updated: | October 12, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
stage IV prostate cancer recurrent prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Hydroxychloroquine Docetaxel Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antineoplastic Agents |