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Sponsored by: |
University of Medicine and Dentistry New Jersey |
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Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00176644 |
Multiple trials have shown the efficacy of estrogen therapy in metastatic prostate cancer, and most recently trials have supported the use of transdermal estrogens (patch) in the patient population with a decreased risk of cardiovascular disease as compared to the oral estrogens. We plan to study(estrogen patch) at a dose of 0.4mg qd. We will evaluate the toxicities and measure quality of life. We will assess PSA response and measurable disease response. This will be a trial available to the Cancer Institute of New Jersey Oncology Group. We will enroll a total of 33 patients. We will plan to enroll 10 at CINJ.Patients will wear the patches (4) continuously. We will obtain blood work and clinic evaluations every three weeks. We will assess quality of life through a questionnaire given to patient every three weeks.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Transdermal Estradiol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Phase II Trial of Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 33 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, New Jersey | |
Cancer Institute of New Jersey | Recruiting |
New Brunswick, New Jersey, United States, 08901 | |
Contact: Dorinda Metzger, RN 732-235-6363 metzgedo@umdnj.edu | |
Principal Investigator: Mark Stein, MD | |
CentraState Healthcare System | Recruiting |
Freehold, New Jersey, United States, 07728 | |
Contact: Kimberly DeRosa, RN 732-294-5047 kderosa@centrastate.com | |
Principal Investigator: Jeffrey Silberberg, MD | |
Morristown Memorial Hospital | Recruiting |
Morristown, New Jersey, United States, 07692 | |
Contact: Rosemary Stefiniw, RN 973-971-5990 rosemary.stefiniw@ahsys.org | |
Principal Investigator: Steven Papish, MD | |
Saint Peter's University Hospital | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: Sherri Shackleford, RN 732-745-8600 ext 118295 sshackelfor@saintpetersuh.com | |
Principal Investigator: Beatriz Lega, MD | |
Robert Wood Johnson University Hospital/CINJ at Hamilton | Recruiting |
Hamilton, New Jersey, United States, 08690 | |
Contact: Arlene Rossi, RN 609-631-6946 arossi@rwjuhh.edu | |
Principal Investigator: Michael Eleff, MD | |
Overlook Hospital | Recruiting |
Summit, New Jersey, United States, 07901 | |
Contact: Eloise Heacock, MA 908-522-2043 Eloise.heacock@ahsys.org | |
Principal Investigator: Daniel Moriarty, MD |
Principal Investigator: | Mark Stein, MD | University of Medicine and Dentistry New Jersey |
Responsible Party: | Cancer Institute of New Jersey ( Mark Stein, M.D. ) |
Study ID Numbers: | 5247, CINJ 080419 |
Study First Received: | September 13, 2005 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00176644 |
Health Authority: | United States: Food and Drug Administration |
prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Benzoates Estradiol 3-benzoate Estradiol valerate Urogenital Neoplasms |
Estradiol 17 beta-cypionate Polyestradiol phosphate Genital Diseases, Male Prostatic Neoplasms Estradiol |
Estrogens Neoplasms Neoplasms by Site Contraceptive Agents Therapeutic Uses Physiological Effects of Drugs |
Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Hormones Pharmacologic Actions |