Official Title: “A Phase II Trial of Climara Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer”

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.

Study Type: Interventional

Study Design: Treatment, Open Label

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Drug: therapeutic estradiol

Primary Measures

• Decrease of 50% in PSA
  • Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cancer Institute of New Jersey

Overall Clinical Trial Officials and Contacts

Mark Stein, MD Study Chair Cancer Institute of New Jersey  

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00255632

Study ID Number: CDR0000445280

ClinicalTrials.gov Identifier: NCT00255632

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database