Transdermal Estradiol in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy and Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00255632
First received: November 18, 2005
Last updated: March 8, 2010
Last verified: March 2010
  Purpose

RATIONALE: Testosterone can cause the growth of prostate cancer cells. Hormone therapy using estradiol may fight prostate cancer by lowering the amount of testosterone the body makes.

PURPOSE: This phase II trial is studying how well transdermal estradiol works in treating patients with metastatic prostate cancer that did not respond to previous hormone therapy and chemotherapy.


Condition Intervention Phase
Prostate Cancer
Biological: therapeutic estradiol
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Climara Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Decrease of 50% in PSA [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: May 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the antitumor activity of transdermal estradiol (Climara^®), as demonstrated by prostate-specific antigen response, in patients with hormone- and chemotherapy-refractory metastatic prostate cancer.

Secondary

  • Determine the toxic effects of this drug in these patients.
  • Determine the measurable disease response in patients treated with this drug.
  • Determine time to progression in patients treated with this drug.
  • Determine the effect of this drug on testosterone levels in patients with androgen-resistant disease.
  • Determine the quality of life of patients treated with this drug.

OUTLINE: Patients wear 4 transdermal estradiol patches (Climara^®) continuously. All patches are changed every 7 days. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 3 weeks during study treatment, and at completion of study treatment.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of metastatic adenocarcinoma of the prostate
  • Failed initial hormone therapy AND experienced disease progression after treatment with ≥ 1 prior chemotherapy regimen containing docetaxel
  • Prostate specific antigen ≥ 10 ng/mL
  • No known CNS metastases

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • At least 4 months

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin < 2 times upper limit of normal (ULN)
  • SGOT and SGPT ≤ 2 times ULN

Renal

  • Creatinine < 2 times ULN

Cardiovascular

  • No history of deep vein thrombosis (DVT)

    • Patients with DVT who have been receiving anticoagulants for ≥ 6 months allowed
  • No New York Heart Association class III or IV heart disease
  • No uncontrolled congestive heart failure
  • No life threatening cardiac dysrhythmia within the past 6 months
  • No history of severe cardiovascular disease
  • Triglycerides ≤ 2 times ULN

Pulmonary

  • No history of pulmonary embolus

Other

  • No other medical condition that would preclude study compliance
  • No known hypersensitivity to estrogen
  • Fertile patients must use effective contraception during and for 10 weeks after completion of study treatment

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since prior flutamide (6 weeks for bicalutamide)

    • Must have progressive disease after withdrawal of antiandrogen
  • No intiation or continuation of luteinizing hormone-releasing hormone (LHRH) agonist therapy during study treatment for patients who have not been on LHRH therapy or who have been on LHRH therapy for < 1 month

    • Concurrent LHRH agonist therapy required for patients who have been on LHRH agonist therapy for > 1 month

Radiotherapy

  • Recovered from prior radiotherapy

Surgery

  • Recovered from prior surgery

Other

  • At least 1 week since prior herbal supplements
  • No concurrent herbal supplements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255632

Locations
United States, New Jersey
CentraState Medical Center
Freehold, New Jersey, United States, 07728
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Mountainside Hospital Cancer Center
Montclair, New Jersey, United States, 07042
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08903
Overlook Hospital
Summit, New Jersey, United States, 07901
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Study Chair: Mark Stein, MD Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Mark Stein, Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
ClinicalTrials.gov Identifier: NCT00255632     History of Changes
Other Study ID Numbers: 080419; CDR0000445280, P30CA072720, CINJ-080419-5247
Study First Received: November 18, 2005
Last Updated: March 8, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Medicine and Dentistry New Jersey:
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on May 16, 2013