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Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00176644
Recruitment Status : Terminated (Treatment ineffective)
First Posted : September 15, 2005
Results First Posted : December 24, 2013
Last Update Posted : December 24, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Brief Summary:
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 the use of transdermal estrogen 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 or disease Intervention/treatment Phase
Prostate Cancer Drug: Transdermal Estradiol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer
Study Start Date : May 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: Transdermal estradiol Drug: Transdermal Estradiol

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.

Primary Outcome Measures :
  1. To Evaluate the Antitumor Activity, as Measured by PSA Response Rate in Patients With Hormone and Chemotherapy Refractory Prostate Cancer. [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. To Measure Quality of Life of Patients Receiving Therapy With the Functional Assessment of Cancer Therapy-Prostate Scale (FACT-P). [ Time Frame: 4 years ]
  2. To Evaluate Measurable Disease Response in Patients With Hormone and Chemotherapy Refractory Prostate Cancer. [ Time Frame: 4 years ]
  3. To Evaluate Time to Progression. [ Time Frame: 4 years ]
  4. To Assess the Plateau Level of Estradiol That is Attained With the Dose of 0.4mg/Day Given Via Transdermal Estradiol Patch and in Addition, Assess the Response on Testosterone in the Androgen Resistant Population. [ Time Frame: 4 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Patients with metastatic prostate adenocarcinoma, who have failed initial hormone therapy and who have had progression after at least one chemotherapy regimen that included docetaxel. Patients on antiandrogens must have progression after withdrawal of the antiandrogen for 4 weeks (flutamide) or 6 weeks (bicalutamide).
  • PSA ≥ 10 ng/ml.
  • Patients who have received LHRH agonist therapy for > 1 month must maintain agonist therapy while on-study. Patients who have not received agonist therapy or received < 1 month of therapy, may not begin or continue agonist therapy while on-study.
  • Age >18 years and an estimated life expectancy of at least 4 months.
  • ECOG performance status ≤ 2 (see Appendix B).
  • Full recovery from the effects of any prior surgery or radiation therapy within 4 weeks of study entry.
  • Serum creatinine ≤ 1.5 x ULN
  • Total bilirubin < ULN
  • Transaminases (SGOT and/or SGPT) ≤ 2 X institutional upper limit.
  • Capacity to give informed, written consent.

Exclusion Criteria

  • Any coexisting medical condition precluding full compliance with the study.
  • Any history of deep venous thrombosis (DVT) or pulmonary embolus. Patients with a DVT on anticoagulants for ≥ 6 months will be eligible.
  • Known CNS metastasis.
  • The discontinuation of flutamide or bicalutamide < 4 or 6 weeks respectively.
  • History of severe cardiovascular disease (AHA class III or IV; see Appendix C), uncontrolled CHF or life threatening cardiac dysrhythmia in the past 6 months.
  • Herbal supplements may not be used while on-study and patients must have discontinued use for ≥ 1 week before entering on-study.
  • Patients with a known hypersensitivity to estrogen.
  • Triglyceride > 200 mg/dl.
  • Prior estramustine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00176644

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United States, New Jersey
CentraState Healthcare System
Freehold, New Jersey, United States, 07728
Robert Wood Johnson University Hospital/CINJ at Hamilton
Hamilton, New Jersey, United States, 08690
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07692
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08903
Overlook Hospital
Summit, New Jersey, United States, 07901
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
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Principal Investigator: Mark Stein, MD Rutgers, The State University of New Jersey

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Responsible Party: University of Medicine and Dentistry of New Jersey Identifier: NCT00176644     History of Changes
Obsolete Identifiers: NCT00255632
Other Study ID Numbers: CDR0000445280
CINJ 080419 ( Other Identifier: Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Results First Posted: December 24, 2013
Last Update Posted: December 24, 2013
Last Verified: November 2013
Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
prostate cancer
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female