Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer
Information source: University of Medicine and Dentistry New Jersey
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: Transdermal Estradiol (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Medicine and Dentistry New Jersey Official(s) and/or principal investigator(s):
Mark Stein, MD, Principal Investigator, Affiliation: University of Medicine and Dentistry New Jersey
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(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.
Clinical Details
Official title: Phase II Trial of Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: To evaluate the antitumor activity, as measured by PSA response rate in patients with hormone and chemotherapy refractory prostate cancer.
Secondary outcome: 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).To evaluate measurable disease response in patients with hormone and chemotherapy refractory prostate cancer. To evaluate time to progression. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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.
Locations and Contacts
Cancer Institute of New Jersey, New Brunswick, New Jersey 08901, United States; Recruiting
Dorinda Metzger, RN, Phone: 732-235-6363, Email: metzgedo@umdnj.edu
Mark Stein, MD, Principal Investigator
CentraState Healthcare System, Freehold, New Jersey 07728, United States; Recruiting
Kimberly DeRosa, RN, Phone: 732-294-5047, Email: kderosa@centrastate.com
Jeffrey Silberberg, MD, Principal Investigator
Morristown Memorial Hospital, Morristown, New Jersey 07692, United States; Recruiting
Rosemary Stefiniw, RN, Phone: 973-971-5990, Email: rosemary.stefiniw@ahsys.org
Steven Papish, MD, Principal Investigator
Overlook Hospital, Summit, New Jersey 07901, United States; Recruiting
Eloise Heacock, MA, Phone: 908-522-2043, Email: Eloise.heacock@ahsys.org
Daniel Moriarty, MD, Principal Investigator
Robert Wood Johnson University Hospital/CINJ at Hamilton, Hamilton, New Jersey 08690, United States; Recruiting
Arlene Rossi, RN, Phone: 609-631-6946, Email: arossi@rwjuhh.edu
Michael Eleff, MD, Principal Investigator
Saint Peter's University Hospital, New Brunswick, New Jersey 08903, United States; Recruiting
Sherri Shackleford, RN, Phone: 732-745-8600, Ext: 118295, Email: sshackelfor@saintpetersuh.com
Beatriz Lega, MD, Principal Investigator
Additional Information
Starting date: January 2005
Ending date: January 2009
Last updated: June 2, 2008
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