Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer - Full Text View

Sponsor:	University of Medicine and Dentistry New Jersey
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00176644

Purpose

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
Prostate Cancer	Drug: Transdermal Estradiol	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial of Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

To evaluate the antitumor activity, as measured by PSA response rate in patients with hormone and chemotherapy refractory prostate cancer. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the toxicities of the use of transdermal estradiol in patients with HRPC after initial chemotherapy. To measure quality of life of patients receiving therapy with the Functional Assessment of Cancer Therapy-Prostate scale (FACT-P). [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
To evaluate measurable disease response in patients with hormone and chemotherapy refractory prostate cancer. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
To evaluate time to progression. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	33
Study Start Date:	May 2005
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176644

Locations

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 New Jersey

Investigators

Principal Investigator:

Mark Stein, MD

University of Medicine and Dentistry New Jersey

More Information

No publications provided

Responsible Party:	Mark Stein, M.D., Cancer Institute of New Jersey
ClinicalTrials.gov Identifier:	NCT00176644 History of Changes
Other Study ID Numbers:	5247, CINJ 080419
Study First Received:	September 13, 2005
Last Updated:	December 10, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Medicine and Dentistry New Jersey:

prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Estradiol
Polyestradiol phosphate
Hormones
Estradiol valerate

Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on February 09, 2012