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| Sponsor: | University of Medicine and Dentistry New Jersey |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00255632 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial of Climara Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer |
| Estimated Enrollment: | 33 |
| Study Start Date: | May 2005 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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 |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No history of deep vein thrombosis (DVT)
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
At least 4 weeks since prior flutamide (6 weeks for bicalutamide)
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
Radiotherapy
Surgery
Other
Contacts and Locations| United States, New Jersey | |
| Cancer Institute of New Jersey at Hamilton | |
| Hamilton, New Jersey, United States, 08690 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | |
| Morristown, New Jersey, United States, 07962 | |
| Saint Peter's University Hospital | |
| New Brunswick, New Jersey, United States, 08903 | |
| Mountainside Hospital Cancer Center | |
| Montclair, New Jersey, United States, 07042 | |
| Overlook Hospital | |
| Summit, New Jersey, United States, 07901 | |
| CentraState Medical Center | |
| Freehold, New Jersey, United States, 07728 | |
| Study Chair: | Mark Stein, MD | Cancer Institute of New Jersey |
More Information
| Responsible Party: | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( Mark Stein ) |
| Study ID Numbers: | 080419; CDR0000445280, P30CA072720, CINJ-080419-5247 |
| Study First Received: | November 18, 2005 |
| Last Updated: | November 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00255632 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
|
Estrogens Genital Neoplasms, Male Prostatic Diseases Contraceptive Agents Physiological Effects of Drugs Estradiol valerate Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Reproductive Control Agents Estradiol 17 beta-cypionate |
Genital Diseases, Male Hormones Pharmacologic Actions Estradiol Neoplasms Neoplasms by Site Therapeutic Uses Estradiol 3-benzoate Polyestradiol phosphate Prostatic Neoplasms |