|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Masking: Open Label Primary Purpose: Treatment |
| 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: | November 2009 |
| Primary Completion Date: | November 2009 (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 | |
| 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 | |
| Study Chair: | Mark Stein, MD | Cancer Institute of New Jersey |
More Information
| 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 |
|
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
|
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 |