Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase II Trial of Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00176644
• Other study ID #: CDR0000445280
• Secondary ID: CINJ 080419P30CA
• Status: Terminated
• Phase: Phase 2
• Start date: May 2005
• Est. completion date: December 2008

Study information

• Verified date: August 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00255632

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	CentraState Healthcare System	Freehold	New Jersey
United States	Robert Wood Johnson University Hospital/CINJ at Hamilton	Hamilton	New Jersey
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	Overlook Hospital	Summit	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With PSA Response	PSA Response is a critical outcome measure used to assess the efficacy of treatments for conditions such as prostate cancer. PSA, or Prostate-Specific Antigen. The PSA Response is a measure of the change in PSA levels before and after a specific treatment intervention.	3 years
Secondary	To Measure Quality of Life of Participants Receiving Therapy With the Functional Assessment of Cancer Therapy-Prostate Scale (FACT-P).		3 years
Secondary	Measurable Disease Response Assessment in Participants With Hormone and Chemotherapy Refractory Prostate Cancer		4 years
Secondary	Time to Progression		3 years
Secondary	Plateau Level of Estradiol and Testosterone Response in Androgen-Resistant Population With 0.4mg/Day Transdermal Estradiol Patch		3 years