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