Clinical trial NCT00176644: Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer
Official title: Phase II Trial of Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-15
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Patients With PSA Response
timeFrame: 3 years
Secondary outcomes:
measure: To Measure Quality of Life of Participants Receiving Therapy With the Functional Assessment of Cancer Therapy-Prostate Scale (FACT-P).
timeFrame: 3 years
measure: Measurable Disease Response Assessment in Participants With Hormone and Chemotherapy Refractory Prostate Cancer
timeFrame: 4 years
measure: Time to Progression
timeFrame: 3 years
measure: Plateau Level of Estradiol and Testosterone Response in Androgen-Resistant Population With 0.4mg/Day Transdermal Estradiol Patch
timeFrame: 3 years
Other outcomes:
Locations:
city: Freehold
country: United States
facility: CentraState Healthcare System
state: New Jersey
city: Hamilton
country: United States
facility: Robert Wood Johnson University Hospital/CINJ at Hamilton
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Summit
country: United States
facility: Overlook Hospital
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Mark Stein, MD
role: PRINCIPAL_INVESTIGATOR
References: