Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer

University of Medicine and Dentistry of New Jersey

Status and phase

Terminated

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Transdermal Estradiol

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00176644

P30CA072720 (U.S. NIH Grant/Contract)

CINJ 080419 (Other Identifier)

CDR0000445280

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.