Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer

NCT00176644 | Terminated Phase 2 Results

• 3 other identifiers: CDR0000445280CINJ 080419P30CA072720
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 6

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.

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• To Measure Quality of Life of Participants Receiving Therapy With the Functional Assessment of Cancer Therapy-Prostate Scale (FACT-P).

  3 years

• Measurable Disease Response Assessment in Participants With Hormone and Chemotherapy Refractory Prostate Cancer

  4 years

• Time to Progression

  3 years

• Plateau Level of Estradiol and Testosterone Response in Androgen-Resistant Population With 0.4mg/Day Transdermal Estradiol Patch

  3 years

Study Arms (1)

Transdermal estradiol

EXPERIMENTAL

Drug: Transdermal Estradiol

Interventions

Transdermal Estradiol DRUG

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.

Transdermal estradiol

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

CentraState Healthcare System

Freehold, New Jersey, 07728, United States

Location

Robert Wood Johnson University Hospital/CINJ at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07692, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Overlook Hospital

Summit, New Jersey, 07901, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Mark Stein
• Organization: Cancer Institute of New Jersey

steinmn@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu

732-235-8675

Study Officials

• Mark Stein, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 13, 2023
• Results First Posted: December 24, 2013

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)