Trial Outcomes & Findings for Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer (NCT NCT00459810)
NCT ID: NCT00459810
Last Updated: 2017-04-28
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
While receiving study agents (on average, 3 months)
Results posted on
2017-04-28
Participant Flow
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.
Participant milestones
| Measure |
Transdermal Estradiol and Paclitaxel Poliglumex
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.
|
|---|---|
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Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer
Baseline characteristics by cohort
| Measure |
Transdermal Estradiol and Paclitaxel Poliglumex
n=21 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: While receiving study agents (on average, 3 months)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.
Outcome measures
| Measure |
Transdermal Estradiol and Paclitaxel Poliglumex
n=21 Participants
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.
|
|---|---|
|
Prostate Specific Antigen (PSA) Response Rate: Number of Subjects With Decreases in PSA of at Least 50%
|
0 Participants
|
SECONDARY outcome
Timeframe: While receiving study agents (on average, 3 months)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).
Outcome measures
| Measure |
Transdermal Estradiol and Paclitaxel Poliglumex
n=21 Participants
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.
|
|---|---|
|
Measurable Disease Response Rate (Soft Tissue)
|
0 Participants
|
SECONDARY outcome
Timeframe: At time of progression by PSA or RECIST criteriaTime from Day 1 to Day of meeting criteria for PSA or Measurable Disease Progression
Outcome measures
| Measure |
Transdermal Estradiol and Paclitaxel Poliglumex
n=21 Participants
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.
|
|---|---|
|
Time to Disease Progression
|
28 Days
Interval 26.0 to 30.0
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SECONDARY outcome
Timeframe: Measured at Date of Death from any causeDefined as time from Day 1 of study regimen to Date of death from any cause.
Outcome measures
| Measure |
Transdermal Estradiol and Paclitaxel Poliglumex
n=21 Participants
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.
|
|---|---|
|
Time to Death
|
7.8 Months
Interval 4.8 to 10.8
|
SECONDARY outcome
Timeframe: Measured after 4 cycles of combination therapyThese 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.
Outcome measures
Outcome data not reported
Adverse Events
Transdermal Estradiol and Paclitaxel Poliglumex
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Transdermal Estradiol and Paclitaxel Poliglumex
n=21 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
4.8%
1/21 • Number of events 1 • While on study agents
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.8%
1/21 • Number of events 1 • While on study agents
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
4.8%
1/21 • Number of events 1 • While on study agents
|
Other adverse events
| Measure |
Transdermal Estradiol and Paclitaxel Poliglumex
n=21 participants at risk
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.
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|---|---|
|
Blood and lymphatic system disorders
hemoglobin decreased
|
42.9%
9/21 • While on study agents
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
3/21 • Number of events 20 • While on study agents
|
|
Blood and lymphatic system disorders
Lymphopenia
|
28.6%
6/21 • While on study agents
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.0%
4/21 • While on study agents
|
|
General disorders
Fatigue
|
28.6%
6/21 • While on study agents
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
3/21 • While on study agents
|
|
Gastrointestinal disorders
Anorexia
|
19.0%
4/21 • While on study agents
|
|
Gastrointestinal disorders
Constipation
|
23.8%
5/21 • While on study agents
|
|
Gastrointestinal disorders
Diarrhea
|
19.0%
4/21 • While on study agents
|
|
Gastrointestinal disorders
Nausea
|
47.6%
10/21 • While on study agents
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
7/21 • While on study agents
|
|
Blood and lymphatic system disorders
Edema
|
9.5%
2/21 • While on study agents
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase increased
|
9.5%
2/21 • While on study agents
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
52.4%
11/21 • While on study agents
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
9.5%
2/21 • While on study agents
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
19.0%
4/21 • While on study agents
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.5%
2/21 • While on study agents
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.8%
5/21 • While on study agents
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
23.8%
5/21 • While on study agents
|
|
Metabolism and nutrition disorders
Hypokalemia
|
19.0%
4/21 • While on study agents
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
6/21 • While on study agents
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.3%
3/21 • While on study agents
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
9.5%
2/21 • While on study agents
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.5%
2/21 • While on study agents
|
|
Reproductive system and breast disorders
Breast pain
|
19.0%
4/21 • While on study agents
|
|
Reproductive system and breast disorders
Gynecomastia
|
19.0%
4/21 • While on study agents
|
Additional Information
Study Coordinator
Oregon Health & Science University Knight Cancer Institute
Phone: (503) 494-2897
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60