Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed Over 18 NCI CINJ-080419-5247 NJ 1805, CINJ-5155V2, NCT00255632, CINJ-NJ1805

Objectives

Primary

1. 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

1. Determine the toxic effects of this drug in these patients.
2. Determine the measurable disease response in patients treated with this drug.
3. Determine time to progression in patients treated with this drug.
4. Determine the effect of this drug on testosterone levels in patients with androgen-resistant disease.
5. Determine the quality of life of patients treated with this drug.

Entry 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

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

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

Expected Enrollment

A total of 33 patients will be accrued for this study.

Outcomes

Decrease of 50% in PSA

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.

Trial Contact Information

Trial Lead Organizations

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Mark Stein, MD, Protocol chair		Ph: 732-235-5773

Registry Information
Official Title		A Phase II Trial of Climara Transdermal Estradiol in Patients with Hormone Refractory Prostate Cancer
Trial Start Date		2005-05-01
Trial Completion Date		2008-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00255632
Date Submitted to PDQ		2005-08-10
Information Last Verified		2008-11-12
NCI Grant/Contract Number		CA72720

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