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| Sponsor: | Cancer Institute of New Jersey |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| 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: | Treatment, Open Label |
| 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: | October 2011 (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 | Recruiting |
| Hamilton, New Jersey, United States, 08690 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey at Ham 609-631-6946 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | Recruiting |
| Morristown, New Jersey, United States, 07962 | |
| Contact: Contact Person 973-971-6100 | |
| Overlook Hospital | Recruiting |
| Summit, New Jersey, United States, 07901 | |
| Contact: Contact Person 908-522-2000 | |
| Principal Investigator: | Robert S. DiPaola, MD | Cancer Institute of New Jersey |
More Information
| Responsible Party: | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( Robert S. DiPaola ) |
| Study ID Numbers: | CDR0000617998, CINJ-080805, 0220080244 |
| Study First Received: | November 5, 2008 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00786682 History of Changes |
| Health Authority: | Unspecified |
|
stage IV prostate cancer recurrent prostate cancer |
|
Anti-Infective Agents Antiprotozoal Agents Genital Neoplasms, Male Prostatic Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Urogenital Neoplasms Enzyme Inhibitors Genital Diseases, Male Pharmacologic Actions |
Docetaxel Antimalarials Antiparasitic Agents Neoplasms Neoplasms by Site Therapeutic Uses Hydroxychloroquine Antirheumatic Agents Prostatic Neoplasms |