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

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ClinicalTrials.gov Identifier: NCT00459810
Recruitment Status : Terminated
First Posted : April 13, 2007
Results First Posted : June 23, 2010
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Tom Beer, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: transdermal estradiol
Drug: paclitaxel poliglumex
Enrollment 21
Recruitment Details Twenty-one patients enrolled in the trial between March 2007 and May 2008 in the medical clinics at Oregon Health & Science University and the University of California at San Francisco.
Pre-assignment Details  
Arm/Group Title Transdermal Estradiol and Paclitaxel Poliglumex
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 21
Completed 21
Not Completed 0
Arm/Group Title Transdermal Estradiol and Paclitaxel Poliglumex
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  19.0%
>=65 years
17
  81.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
70  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
0
   0.0%
Male
21
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
1.Primary Outcome
Title Prostate Specific Antigen (PSA) Response Rate: Number of Subjects With Decreases in PSA of at Least 50%
Hide Description 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.
Time Frame While receiving study agents (on average, 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transdermal Estradiol and Paclitaxel Poliglumex
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: Participants
0
2.Secondary Outcome
Title Measurable Disease Response Rate (Soft Tissue)
Hide Description 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 Frame While receiving study agents (on average, 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transdermal Estradiol and Paclitaxel Poliglumex
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: Participants
0
3.Secondary Outcome
Title Time to Disease Progression
Hide Description Time from Day 1 to Day of meeting criteria for PSA or Measurable Disease Progression
Time Frame At time of progression by PSA or RECIST criteria
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transdermal Estradiol and Paclitaxel Poliglumex
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: Days
28
(26 to 30)
4.Secondary Outcome
Title Time to Death
Hide Description Defined as time from Day 1 of study regimen to Date of death from any cause.
Time Frame Measured at Date of Death from any cause
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transdermal Estradiol and Paclitaxel Poliglumex
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: Months
7.8
(4.8 to 10.8)
5.Secondary Outcome
Title Correlation of Levels of Serum Estradiol, Serum Cathepsin B, and Bone Turnover Markers With PSA Response
Hide Description 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.
Time Frame Measured after 4 cycles of combination therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transdermal Estradiol and Paclitaxel Poliglumex
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame While on study agents
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transdermal Estradiol and Paclitaxel Poliglumex
Hide Arm/Group Description 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.
All-Cause Mortality
Transdermal Estradiol and Paclitaxel Poliglumex
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Transdermal Estradiol and Paclitaxel Poliglumex
Affected / at Risk (%) # Events
Total   3/21 (14.29%)    
Gastrointestinal disorders   
Gastric Hemorrhage 1 [1]  1/21 (4.76%)  1
Nausea and Vomiting 2 [2]  1/21 (4.76%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonitis 2 [3]  1/21 (4.76%)  1
1
Term from vocabulary, CTCAE v. 3.0
2
Term from vocabulary, CTCAE (3.0)
[1]
Subject admitted for gastric hemorrhage and thrombocytopenia. Event determined to be possibly related to study agents.
[2]
Subject admitted for intractable nausea and vomiting. Abdominal ultrasound was normal. Event deemed possibly related to study agents
[3]
Subject admitted with lethargy, cough and elevated temperature. Chest X-ray demonstrated pneumonitis. Event determined to be possibly related to study agents.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Transdermal Estradiol and Paclitaxel Poliglumex
Affected / at Risk (%) # Events
Total   20/21 (95.24%)    
Blood and lymphatic system disorders   
hemoglobin decreased  9/21 (42.86%) 
Leukopenia  3/21 (14.29%)  20
Lymphopenia  6/21 (28.57%) 
Thrombocytopenia  4/21 (19.05%) 
Edema  2/21 (9.52%) 
Gastrointestinal disorders   
Anorexia  4/21 (19.05%) 
Constipation  5/21 (23.81%) 
Diarrhea  4/21 (19.05%) 
Nausea  10/21 (47.62%) 
Vomiting  7/21 (33.33%) 
General disorders   
Fatigue  6/21 (28.57%) 
Metabolism and nutrition disorders   
Alkaline Phosphatase increased  2/21 (9.52%) 
Aspartate aminotransferase increased  11/21 (52.38%) 
Hyperbilirubinemia  2/21 (9.52%) 
Hyperglycemia  4/21 (19.05%) 
Hyperkalemia  2/21 (9.52%) 
Hypoalbuminemia  5/21 (23.81%) 
Hypocalcemia  5/21 (23.81%) 
Hypokalemia  4/21 (19.05%) 
Hyponatremia  6/21 (28.57%) 
Hypophosphatemia  3/21 (14.29%) 
Nervous system disorders   
Peripheral Sensory Neuropathy  2/21 (9.52%) 
Reproductive system and breast disorders   
Breast pain  4/21 (19.05%) 
Gynecomastia  4/21 (19.05%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  2/21 (9.52%) 
Skin and subcutaneous tissue disorders   
Rash  3/21 (14.29%) 
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Coordinator
Organization: Oregon Health & Science University Knight Cancer Institute
Phone: (503) 494-2897
EMail: eilersk@ohsu.edu
Layout table for additonal information
Responsible Party: Tom Beer, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00459810     History of Changes
Other Study ID Numbers: CDR0000540438
OHSU-2656 ( Other Identifier: OHSU IRB )
First Submitted: April 11, 2007
First Posted: April 13, 2007
Results First Submitted: May 25, 2010
Results First Posted: June 23, 2010
Last Update Posted: April 28, 2017