Trial Outcomes & Findings for Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer (NCT NCT00699907)
NCT ID: NCT00699907
Last Updated: 2018-07-24
Results Overview
CSF-1 levels were measured by immunohistochemistry (IHC). The modified H-Score assess extent of nuclear immunoreactivity applicable to steroid receptors. The modified H-scores total range is 0-300. A lower modified H-score indicates weakly staining nuclei. A higher modified H-score indicated strongly staining nuclei. This applies to all measures.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
127 participants
Primary outcome timeframe
Surgery
Results posted on
2018-07-24
Participant Flow
Participants were recruited from the medical clinic prior to oophorectomy. Participants were recruited from January 2007 until June 2011.
Participants were assigned to groups immediately after being enrolled.
Participant milestones
| Measure |
Treatment Arm
Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
|
High Risk Arm
High risk patients underwent risk-reducing salpingo-oophorectomy.
|
Low Risk Arm
Low risk patients underwent salpingo-oophorectomy for a medical indication.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
57
|
56
|
|
Overall Study
COMPLETED
|
12
|
47
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
10
|
8
|
Reasons for withdrawal
| Measure |
Treatment Arm
Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
|
High Risk Arm
High risk patients underwent risk-reducing salpingo-oophorectomy.
|
Low Risk Arm
Low risk patients underwent salpingo-oophorectomy for a medical indication.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
|
Overall Study
No usable sample
|
0
|
9
|
8
|
Baseline Characteristics
Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=12 Participants
Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
flutamide: Patients receive oral flutamide (125 MG/DAY) once daily for 6 weeks in the absence of unacceptable toxicity.
|
High Risk Arm
n=47 Participants
High risk patients underwent risk-reducing salpingo-oophorectomy.
|
Low Risk Arm
n=48 Participants
Low risk patients underwent salpingo-oophorectomy for a medical indication.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.2 years
n=99 Participants
|
46.9 years
n=107 Participants
|
51.7 years
n=206 Participants
|
48.9 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
107 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
47 participants
n=107 Participants
|
48 participants
n=206 Participants
|
107 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: SurgeryPopulation: The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated
CSF-1 levels were measured by immunohistochemistry (IHC). The modified H-Score assess extent of nuclear immunoreactivity applicable to steroid receptors. The modified H-scores total range is 0-300. A lower modified H-score indicates weakly staining nuclei. A higher modified H-score indicated strongly staining nuclei. This applies to all measures.
Outcome measures
| Measure |
Treatment Arm
n=7 Participants
Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
|
High Risk Arm
n=24 Participants
High risk patients underwent risk-reducing salpingo-oophorectomy.
|
Low Risk Arm
n=15 Participants
Low risk patients underwent salpingo-oophorectomy for a medical indication.
|
|---|---|---|---|
|
Colony Stimulating Factor (CSF-1) Expression in Ovarian Endosalpingiosis
|
5 Modified H-Score
Interval 0.0 to 210.0
|
130 Modified H-Score
Interval 0.0 to 300.0
|
50 Modified H-Score
Interval 5.0 to 270.0
|
PRIMARY outcome
Timeframe: SurgeryPopulation: The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated
CSF-1 levels were measured by immunohistochemistry (IHC).
Outcome measures
| Measure |
Treatment Arm
n=8 Participants
Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
|
High Risk Arm
n=42 Participants
High risk patients underwent risk-reducing salpingo-oophorectomy.
|
Low Risk Arm
n=39 Participants
Low risk patients underwent salpingo-oophorectomy for a medical indication.
|
|---|---|---|---|
|
Colony Stimulating Factor (CSF-1) Expression in Ovarian Epithelium
|
0 Histo-score (H-Score)
Interval 0.0 to 30.0
|
50 Histo-score (H-Score)
Interval 0.0 to 210.0
|
0 Histo-score (H-Score)
Interval 0.0 to 120.0
|
PRIMARY outcome
Timeframe: SurgeryCSF-1 levels were measured by immunohistochemistry (IHC).
Outcome measures
| Measure |
Treatment Arm
n=11 Participants
Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
|
High Risk Arm
n=45 Participants
High risk patients underwent risk-reducing salpingo-oophorectomy.
|
Low Risk Arm
n=43 Participants
Low risk patients underwent salpingo-oophorectomy for a medical indication.
|
|---|---|---|---|
|
Colony Stimulating Factor (CSF-1) Expression in Ovarian Stroma
|
5 Histo-score (H-Score)
Interval 0.0 to 80.0
|
40 Histo-score (H-Score)
Interval 5.0 to 160.0
|
35 Histo-score (H-Score)
Interval 5.0 to 180.0
|
PRIMARY outcome
Timeframe: SurgeryPopulation: The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated
CSF-1R levels were measured by immunohistochemistry (IHC).
Outcome measures
| Measure |
Treatment Arm
n=6 Participants
Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
|
High Risk Arm
n=21 Participants
High risk patients underwent risk-reducing salpingo-oophorectomy.
|
Low Risk Arm
n=16 Participants
Low risk patients underwent salpingo-oophorectomy for a medical indication.
|
|---|---|---|---|
|
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Endosalpingiosis
|
15 Histo-score (H-Score)
Interval 0.0 to 60.0
|
160 Histo-score (H-Score)
Interval 5.0 to 285.0
|
75 Histo-score (H-Score)
Interval 5.0 to 195.0
|
PRIMARY outcome
Timeframe: SurgeryCSF-1R levels were measured by immunohistochemistry (IHC).
Outcome measures
| Measure |
Treatment Arm
n=12 Participants
Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
|
High Risk Arm
n=41 Participants
High risk patients underwent risk-reducing salpingo-oophorectomy.
|
Low Risk Arm
n=36 Participants
Low risk patients underwent salpingo-oophorectomy for a medical indication.
|
|---|---|---|---|
|
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Epithelium
|
0 Histo-score (H-Score)
Interval 0.0 to 160.0
|
40 Histo-score (H-Score)
Interval 0.0 to 270.0
|
20 Histo-score (H-Score)
Interval 2.0 to 270.0
|
PRIMARY outcome
Timeframe: SurgeryPopulation: The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated
CSF-1R levels were measured by immunohistochemistry (IHC).
Outcome measures
| Measure |
Treatment Arm
n=12 Participants
Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
|
High Risk Arm
n=42 Participants
High risk patients underwent risk-reducing salpingo-oophorectomy.
|
Low Risk Arm
n=42 Participants
Low risk patients underwent salpingo-oophorectomy for a medical indication.
|
|---|---|---|---|
|
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Stroma
|
20 Histo-score (H-Score)
Interval 0.0 to 40.0
|
40 Histo-score (H-Score)
Interval 0.0 to 210.0
|
53 Histo-score (H-Score)
Interval 0.0 to 195.0
|
PRIMARY outcome
Timeframe: SurgeryErbB4 levels were measured by immunohistochemistry (IHC).
Outcome measures
| Measure |
Treatment Arm
n=7 Participants
Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
|
High Risk Arm
n=19 Participants
High risk patients underwent risk-reducing salpingo-oophorectomy.
|
Low Risk Arm
n=9 Participants
Low risk patients underwent salpingo-oophorectomy for a medical indication.
|
|---|---|---|---|
|
Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Endosalpingiosis
|
5 Histo-score (H-Score)
Interval 0.0 to 30.0
|
60 Histo-score (H-Score)
Interval 5.0 to 270.0
|
10 Histo-score (H-Score)
Interval 5.0 to 270.0
|
PRIMARY outcome
Timeframe: SurgeryPopulation: The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated
ErbB4 levels were measured by immunohistochemistry (IHC).
Outcome measures
| Measure |
Treatment Arm
n=8 Participants
Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
|
High Risk Arm
n=33 Participants
High risk patients underwent risk-reducing salpingo-oophorectomy.
|
Low Risk Arm
n=20 Participants
Low risk patients underwent salpingo-oophorectomy for a medical indication.
|
|---|---|---|---|
|
Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Epithelium
|
0 Histo-score (H-Score)
Interval 0.0 to 15.0
|
55 Histo-score (H-Score)
Interval 0.0 to 270.0
|
0 Histo-score (H-Score)
Interval 0.0 to 285.0
|
PRIMARY outcome
Timeframe: SurgeryPopulation: The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated
ErbB4 levels were measured by immunohistochemistry (IHC).
Outcome measures
| Measure |
Treatment Arm
n=11 Participants
Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
|
High Risk Arm
n=36 Participants
High risk patients underwent risk-reducing salpingo-oophorectomy.
|
Low Risk Arm
n=23 Participants
Low risk patients underwent salpingo-oophorectomy for a medical indication.
|
|---|---|---|---|
|
Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Stroma
|
10 Histo-score (H-Score)
Interval 0.0 to 60.0
|
90 Histo-score (H-Score)
Interval 10.0 to 285.0
|
30 Histo-score (H-Score)
Interval 10.0 to 255.0
|
Adverse Events
Treatment Arm
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
High Risk Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Risk Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Arm
n=12 participants at risk
Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
|
High Risk Arm
n=47 participants at risk
High risk patients underwent risk-reducing salpingo-oophorectomy.
|
Low Risk Arm
n=48 participants at risk
Low risk patients underwent salpingo-oophorectomy for a medical indication.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Burn
|
8.3%
1/12 • Number of events 1
|
0.00%
0/47
|
0.00%
0/48
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1
|
0.00%
0/47
|
0.00%
0/48
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1
|
0.00%
0/47
|
0.00%
0/48
|
|
Endocrine disorders
Endocrine
|
8.3%
1/12 • Number of events 1
|
0.00%
0/47
|
0.00%
0/48
|
|
Blood and lymphatic system disorders
Hemoglobin
|
8.3%
1/12 • Number of events 1
|
0.00%
0/47
|
0.00%
0/48
|
|
General disorders
Hot flashes
|
8.3%
1/12 • Number of events 1
|
0.00%
0/47
|
0.00%
0/48
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
8.3%
1/12 • Number of events 1
|
0.00%
0/47
|
0.00%
0/48
|
|
General disorders
Pain - Other
|
8.3%
1/12 • Number of events 1
|
0.00%
0/47
|
0.00%
0/48
|
|
Blood and lymphatic system disorders
Hyponatremia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/47
|
0.00%
0/48
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
8.3%
1/12 • Number of events 1
|
0.00%
0/47
|
0.00%
0/48
|
|
Renal and urinary disorders
Urine color change
|
25.0%
3/12 • Number of events 3
|
0.00%
0/47
|
0.00%
0/48
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - other
|
8.3%
1/12 • Number of events 2
|
0.00%
0/47
|
0.00%
0/48
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2
|
0.00%
0/47
|
0.00%
0/48
|
|
General disorders
Pain - Head/headache
|
16.7%
2/12 • Number of events 2
|
0.00%
0/47
|
0.00%
0/48
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place