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Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00176644
Recruitment Status : Terminated (Treatment ineffective)
First Posted : September 15, 2005
Results First Posted : December 24, 2013
Last Update Posted : December 24, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Transdermal Estradiol
Enrollment 23
Recruitment Details Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and 4 community hospitals within the Cancer Institute of New Jersey Oncology Group from May 2005 through April 2008.
Pre-assignment Details  
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 23
Completed 22
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  17.4%
>=65 years
19
  82.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
72.4  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
0
   0.0%
Male
23
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
1.Primary Outcome
Title To Evaluate the Antitumor Activity, as Measured by PSA Response Rate in Patients With Hormone and Chemotherapy Refractory Prostate Cancer.
Hide Description [Not Specified]
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: Response rate (percentage)
8.7
2.Secondary Outcome
Title To Measure Quality of Life of Patients Receiving Therapy With the Functional Assessment of Cancer Therapy-Prostate Scale (FACT-P).
Hide Description [Not Specified]
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title To Evaluate Measurable Disease Response in Patients With Hormone and Chemotherapy Refractory Prostate Cancer.
Hide Description [Not Specified]
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title To Evaluate Time to Progression.
Hide Description [Not Specified]
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title To Assess the Plateau Level of Estradiol That is Attained With the Dose of 0.4mg/Day Given Via Transdermal Estradiol Patch and in Addition, Assess the Response on Testosterone in the Androgen Resistant Population.
Hide Description [Not Specified]
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 3 years and 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description

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.

All-Cause Mortality
Transdermal Estradiol
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Transdermal Estradiol
Affected / at Risk (%) # Events
Total   5/23 (21.74%)    
Blood and lymphatic system disorders   
Hemoglobin * 1  2/23 (8.70%)  2
Platelets * 1  1/23 (4.35%)  1
Gastrointestinal disorders   
Constipation * 1  1/23 (4.35%)  1
General disorders   
Pain - Bone * 1  1/23 (4.35%)  1
Investigations   
AST, SGOT(serum glutamic oxaloacetic transaminase) * 1  1/23 (4.35%)  1
Alkaline phosphatase * 1  1/23 (4.35%)  1
Nervous system disorders   
Neuropathy: sensory * 1  1/23 (4.35%)  1
Renal and urinary disorders   
Obstruction, GU - Urethra * 1  1/23 (4.35%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumothorax * 1  1/23 (4.35%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Transdermal Estradiol
Affected / at Risk (%) # Events
Total   18/23 (78.26%)    
Blood and lymphatic system disorders   
Hemoglobin * 1  2/23 (8.70%)  5
Edema: limb * 1  3/23 (13.04%)  5
Gastrointestinal disorders   
Nausea * 1  3/23 (13.04%)  3
Constipation * 1  2/23 (8.70%)  2
General disorders   
Pain - Bone * 1  3/23 (13.04%)  3
Pain - Breast * 1  3/23 (13.04%)  3
Pain - Extremity-limb * 1  3/23 (13.04%)  3
Pain - Back * 1  3/23 (13.04%)  3
Pain - Neck * 1  2/23 (8.70%)  2
Pain - Other (Specify, __) * 1  2/23 (8.70%)  2
Fatigue (asthenia, lethargy, malaise) * 1  5/23 (21.74%)  5
Sweating (diaphoresis) * 1  2/23 (8.70%)  2
Investigations   
Albumin, serum-low (hypoalbuminemia) * 1  2/23 (8.70%)  2
Calcium, serum-low (hypocalcemia) * 1  2/23 (8.70%)  2
Nervous system disorders   
Neuropathy: sensory * 1  2/23 (8.70%)  2
Reproductive system and breast disorders   
Gynecomastia * 1  2/23 (8.70%)  2
Skin and subcutaneous tissue disorders   
Pruritus/itching * 1  2/23 (8.70%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mark Stein
Organization: Cancer Institute of New Jersey
Phone: 732-235-8675
EMail: steinmn@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu
Layout table for additonal information
Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00176644     History of Changes
Obsolete Identifiers: NCT00255632
Other Study ID Numbers: CDR0000445280
CINJ 080419 ( Other Identifier: Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 15, 2005
Results First Submitted: November 5, 2013
Results First Posted: December 24, 2013
Last Update Posted: December 24, 2013