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Hormones

Estradiol 17 beta-cypionate

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Estradiol

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Estrogens

Hormone Antagonists

application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.

The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.

Transdermal Estradiol

Mark Stein, MD

Multiple trials have shown the efficacy of estrogen therapy in metastatic prostate cancer, and most recently trials have supported the use of transdermal estrogens (patch) in the patient population with a decreased risk of cardiovascular disease as compared to the oral estrogens. We plan to study the use of transdermal estrogen at a dose of 0.4mg qd. We will evaluate the toxicities and measure quality of life. We will assess PSA response and measurable disease response. This will be a trial available to the Cancer Institute of New Jersey Oncology Group. We will enroll a total of 33 patients. We will plan to enroll 10 at CINJ.Patients will wear the patches (4) continuously. We will obtain blood work and clinic evaluations every three weeks. We will assess quality of life through a questionnaire given to patient every three weeks.

Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer

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

PSA Response is a critical outcome measure used to assess the efficacy of treatments for conditions such as prostate cancer. PSA, or Prostate-Specific Antigen. The PSA Response is a measure of the change in PSA levels before and after a specific treatment intervention.

National Cancer Institute (NCI)

University of Medicine and Dentistry of New Jersey

Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.

The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Mark Stein

Percentage of Patients With PSA Response

Outcome Measure was pre-specified to be assessed based on achieving a certain pre-requisite response rate

To Measure Quality of Life of Participants Receiving Therapy With the Functional Assessment of Cancer Therapy-Prostate Scale (FACT-P).

Measurable Disease Response Assessment in Participants With Hormone and Chemotherapy Refractory Prostate Cancer

Time to Progression

Plateau Level of Estradiol and Testosterone Response in Androgen-Resistant Population With 0.4mg/Day Transdermal Estradiol Patch

Overall Study

Symptoms and General Pathology

Adenocarcinoma

Recurrence

Antineoplastic Agents

Androgens

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Paclitaxel poliglumex

Tubulin Modulators

Antimitotic Agents

Transdermal estradiol given 0.2mg/day for duration of study.

transdermal estradiol

Paclitaxel poliglumex (PPX) is a macromolecular polymer-drug conjugate of paclitaxel. PPX was given every 28 days, at a dose of 150 mg/m2

paclitaxel poliglumex

Tomasz M. Beer, MD

RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estradiol may kill prostate cancer cells that no longer respond to hormone therapy. Giving paclitaxel poliglumex together with estradiol may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel poliglumex together with estradiol works in treating patients with stage IV prostate cancer.

OBJECTIVES:

Primary

* Determine the PSA response rate in patients with androgen independent metastatic prostate cancer treated with paclitaxel poliglumex and transdermal estradiol.

Secondary

* Determine the toxicity of this regimen in these patients.
* Determine the response rate in patients treated with this regimen.
* Determine the time to PSA progression and measurable disease progression in patients treated with this regimen.
* Determine time to death from all causes in patients treated with this regimen.
* Correlate levels of serum estradiol, serum cathepsin B, and bone turnover markers with PSA response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive transdermal estradiol continuously (patches changed every 7 days) until the PSA level rises. Patients whose PSA increases above baseline or PSA decreases \< 10% after 4 weeks of estradiol therapy or whose serum PSA reduction is \< 50% after 12 weeks of estradiol therapy also receive paclitaxel poliglumex therapy. These patients receive paclitaxel poliglumex IV over 10-20 minutes on day 1. Treatment with paclitaxel poliglumex repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer

A Phase II Study of Paclitaxel Poliglumex (PPX) in Combination With Transdermal Estradiol for the Treatment of Androgen Independent Prostate Cancer After Docetaxel Chemotherapy

PSA response rate is defined at the number of patients who experienced a PSA decline of equal to or greater than 50%, confirmed by a second measurement at least 4 weeks later.

Measurable disease response rate by RECIST criteria. Response is defined as at least a 30% decrease in the sum of the longest diameter in measurable lesions (larger than 10mm at baseline).

Time from Day 1 to Day of meeting criteria for PSA or Measurable Disease Progression

Defined as time from Day 1 of study regimen to Date of death from any cause.

These correlative analyses were not completed. As there were no PSA responses, it was not possible to correlate serum estradiol, serum cathepsin B, or bone turnover markers with PSA response.

OHSU Knight Cancer Institute

Principal Investigator

All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.

Transdermal Estradiol and Paclitaxel Poliglumex

Study Coordinator

Prostate Specific Antigen (PSA) Response Rate: Number of Subjects With Decreases in PSA of at Least 50%

Measurable Disease Response Rate (Soft Tissue)

Time to Disease Progression

Time to Death

Correlation of Levels of Serum Estradiol, Serum Cathepsin B, and Bone Turnover Markers With PSA Response

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer	NCT00176644	Prostate Cancer	Transdermal Est...	18 Years -	Rutgers, The State University of New Jersey
Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer	NCT00459810	Prostate Cancer	transdermal est... paclitaxel poli...	18 Years - 120 Years	OHSU Knight Cancer Institute
Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer	NCT00176644	Prostate Cancer	Transdermal Est...	18 Years -	Rutgers, The State University of New Jersey

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