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A Phase II Trial of Climara Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Phase II Trial of Climara Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Decrease of 50% in PSA

Safety Issue:

No

Principal Investigator

Mark Stein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

080419; CDR0000445280

NCT ID:

NCT00255632

Start Date:

May 2005

Completion Date:

November 2009

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Overlook HospitalSummit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Mountainside Hospital Cancer CenterMontclair, New Jersey  07042
CentraState Medical CenterFreehold, New Jersey  07728