Transdermal Estradiol in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy and Chemotherapy
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: therapeutic estradiol (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Cancer Institute of New Jersey Official(s) and/or principal investigator(s):
Mark Stein, MD, Study Chair, Affiliation: Cancer Institute of New Jersey
Summary
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.
Clinical Details
Official title: A Phase II Trial of Climara Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer
Study design: Treatment, Open Label
Primary outcome: Decrease of 50% in PSA
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Cancer Institute of New Jersey at Hamilton, Hamilton, New Jersey 08690, United States; Recruiting
Clinical Trials Office - Cancer Institute of New Jersey at Ham, Phone: 609-631-6946
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States; Recruiting
Clinical Trials Office - Cancer Institute of New Jersey, Phone: 732-235-8675
Carol G. Simon Cancer Center at Morristown Memorial Hospital, Morristown, New Jersey 07962, United States; Recruiting
Contact Person, Phone: 973-971-6100
CentraState Medical Center, Freehold, New Jersey 07728, United States; Recruiting
Contact Person, Phone: 732-431-2000
Overlook Hospital, Summit, New Jersey 07901, United States; Recruiting
Contact Person, Phone: 908-522-2000
Saint Peter's University Hospital, New Brunswick, New Jersey 08903, United States; Recruiting
Contact Person, Phone: 732-745-8600
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: May 2005
Last updated: May 23, 2008
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