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Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00699907
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : January 5, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Ovarian Cancer
Intervention Drug: flutamide
Enrollment 127
Recruitment Details Participants were recruited from the medical clinic prior to oophorectomy. Participants were recruited from January 2007 until June 2011.
Pre-assignment Details Participants were assigned to groups immediately after being enrolled.
Arm/Group Title Treatment Arm High Risk Arm Low Risk Arm
Hide Arm/Group Description 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 patients underwent risk-reducing salpingo-oophorectomy. Low risk patients underwent salpingo-oophorectomy for a medical indication.
Period Title: Overall Study
Started 14 57 56
Completed 12 47 48
Not Completed 2 10 8
Reason Not Completed
Withdrawal by Subject             2             1             0
No usable sample             0             9             8
Arm/Group Title Treatment Arm High Risk Arm Low Risk Arm Total
Hide Arm/Group Description

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 patients underwent risk-reducing salpingo-oophorectomy. Low risk patients underwent salpingo-oophorectomy for a medical indication. Total of all reporting groups
Overall Number of Baseline Participants 12 47 48 107
Hide Baseline Analysis Population Description
The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants 47 participants 48 participants 107 participants
45.2
(36 to 58)
46.9
(27 to 66)
51.7
(21 to 81)
48.9
(21 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 47 participants 48 participants 107 participants
Female
12
 100.0%
47
 100.0%
48
 100.0%
107
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 47 participants 48 participants 107 participants
12 47 48 107
1.Primary Outcome
Title Colony Stimulating Factor (CSF-1) Expression in Ovarian Endosalpingiosis
Hide Description

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.

Time Frame Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated
Arm/Group Title Treatment Arm High Risk Arm Low Risk Arm
Hide Arm/Group Description:
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 patients underwent risk-reducing salpingo-oophorectomy.
Low risk patients underwent salpingo-oophorectomy for a medical indication.
Overall Number of Participants Analyzed 7 24 15
Median (Full Range)
Unit of Measure: Modified H-Score
5
(0 to 210)
130
(0 to 300)
50
(5 to 270)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm, High Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Risk Arm, Low Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
2.Primary Outcome
Title Colony Stimulating Factor (CSF-1) Expression in Ovarian Epithelium
Hide Description CSF-1 levels were measured by immunohistochemistry (IHC).
Time Frame Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated
Arm/Group Title Treatment Arm High Risk Arm Low Risk Arm
Hide Arm/Group Description:
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 patients underwent risk-reducing salpingo-oophorectomy.
Low risk patients underwent salpingo-oophorectomy for a medical indication.
Overall Number of Participants Analyzed 8 42 39
Median (Full Range)
Unit of Measure: Histo-score (H-Score)
0
(0 to 30)
50
(0 to 210)
0
(0 to 120)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm, High Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Risk Arm, Low Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
3.Primary Outcome
Title Colony Stimulating Factor (CSF-1) Expression in Ovarian Stroma
Hide Description CSF-1 levels were measured by immunohistochemistry (IHC).
Time Frame Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm High Risk Arm Low Risk Arm
Hide Arm/Group Description:
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 patients underwent risk-reducing salpingo-oophorectomy.
Low risk patients underwent salpingo-oophorectomy for a medical indication.
Overall Number of Participants Analyzed 11 45 43
Median (Full Range)
Unit of Measure: Histo-score (H-Score)
5
(0 to 80)
40
(5 to 160)
35
(5 to 180)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm, High Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Risk Arm, Low Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
4.Primary Outcome
Title Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Endosalpingiosis
Hide Description CSF-1R levels were measured by immunohistochemistry (IHC).
Time Frame Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated
Arm/Group Title Treatment Arm High Risk Arm Low Risk Arm
Hide Arm/Group Description:
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 patients underwent risk-reducing salpingo-oophorectomy.
Low risk patients underwent salpingo-oophorectomy for a medical indication.
Overall Number of Participants Analyzed 6 21 16
Median (Full Range)
Unit of Measure: Histo-score (H-Score)
15
(0 to 60)
160
(5 to 285)
75
(5 to 195)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm, High Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Risk Arm, Low Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
5.Primary Outcome
Title Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Epithelium
Hide Description CSF-1R levels were measured by immunohistochemistry (IHC).
Time Frame Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm High Risk Arm Low Risk Arm
Hide Arm/Group Description:
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 patients underwent risk-reducing salpingo-oophorectomy.
Low risk patients underwent salpingo-oophorectomy for a medical indication.
Overall Number of Participants Analyzed 12 41 36
Median (Full Range)
Unit of Measure: Histo-score (H-Score)
0
(0 to 160)
40
(0 to 270)
20
(2 to 270)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm, High Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Risk Arm, Low Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
6.Primary Outcome
Title Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Stroma
Hide Description CSF-1R levels were measured by immunohistochemistry (IHC).
Time Frame Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated
Arm/Group Title Treatment Arm High Risk Arm Low Risk Arm
Hide Arm/Group Description:
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 patients underwent risk-reducing salpingo-oophorectomy.
Low risk patients underwent salpingo-oophorectomy for a medical indication.
Overall Number of Participants Analyzed 12 42 42
Median (Full Range)
Unit of Measure: Histo-score (H-Score)
20
(0 to 40)
40
(0 to 210)
53
(0 to 195)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm, High Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Risk Arm, Low Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
7.Primary Outcome
Title Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Endosalpingiosis
Hide Description ErbB4 levels were measured by immunohistochemistry (IHC).
Time Frame Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm High Risk Arm Low Risk Arm
Hide Arm/Group Description:
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 patients underwent risk-reducing salpingo-oophorectomy.
Low risk patients underwent salpingo-oophorectomy for a medical indication.
Overall Number of Participants Analyzed 7 19 9
Median (Full Range)
Unit of Measure: Histo-score (H-Score)
5
(0 to 30)
60
(5 to 270)
10
(5 to 270)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm, High Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Risk Arm, Low Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
8.Primary Outcome
Title Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Epithelium
Hide Description ErbB4 levels were measured by immunohistochemistry (IHC).
Time Frame Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated
Arm/Group Title Treatment Arm High Risk Arm Low Risk Arm
Hide Arm/Group Description:
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 patients underwent risk-reducing salpingo-oophorectomy.
Low risk patients underwent salpingo-oophorectomy for a medical indication.
Overall Number of Participants Analyzed 8 33 20
Median (Full Range)
Unit of Measure: Histo-score (H-Score)
0
(0 to 15)
55
(0 to 270)
0
(0 to 285)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm, High Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Risk Arm, Low Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
9.Primary Outcome
Title Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Stroma
Hide Description ErbB4 levels were measured by immunohistochemistry (IHC).
Time Frame Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated
Arm/Group Title Treatment Arm High Risk Arm Low Risk Arm
Hide Arm/Group Description:
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 patients underwent risk-reducing salpingo-oophorectomy.
Low risk patients underwent salpingo-oophorectomy for a medical indication.
Overall Number of Participants Analyzed 11 36 23
Median (Full Range)
Unit of Measure: Histo-score (H-Score)
10
(0 to 60)
90
(10 to 285)
30
(10 to 255)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm, High Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Risk Arm, Low Risk Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Arm High Risk Arm Low Risk Arm
Hide Arm/Group Description 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 patients underwent risk-reducing salpingo-oophorectomy. Low risk patients underwent salpingo-oophorectomy for a medical indication.
All-Cause Mortality
Treatment Arm High Risk Arm Low Risk Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Treatment Arm High Risk Arm Low Risk Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/47 (0.00%)      0/48 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Arm High Risk Arm Low Risk Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/12 (75.00%)      0/47 (0.00%)      0/48 (0.00%)    
Blood and lymphatic system disorders       
Hemoglobin   1/12 (8.33%)  1 0/47 (0.00%)  0 0/48 (0.00%)  0
Hyponatremia   1/12 (8.33%)  1 0/47 (0.00%)  0 0/48 (0.00%)  0
Endocrine disorders       
Endocrine   1/12 (8.33%)  1 0/47 (0.00%)  0 0/48 (0.00%)  0
Gastrointestinal disorders       
Constipation   1/12 (8.33%)  1 0/47 (0.00%)  0 0/48 (0.00%)  0
Diarrhea   1/12 (8.33%)  1 0/47 (0.00%)  0 0/48 (0.00%)  0
Nausea   2/12 (16.67%)  2 0/47 (0.00%)  0 0/48 (0.00%)  0
General disorders       
Hot flashes   1/12 (8.33%)  1 0/47 (0.00%)  0 0/48 (0.00%)  0
Pain - Other   1/12 (8.33%)  1 0/47 (0.00%)  0 0/48 (0.00%)  0
Pain - Head/headache   2/12 (16.67%)  2 0/47 (0.00%)  0 0/48 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Pain - Muscle   1/12 (8.33%)  1 0/47 (0.00%)  0 0/48 (0.00%)  0
Musculoskeletal/Soft Tissue - other   1/12 (8.33%)  2 0/47 (0.00%)  0 0/48 (0.00%)  0
Renal and urinary disorders       
Urinary frequency/urgency   1/12 (8.33%)  1 0/47 (0.00%)  0 0/48 (0.00%)  0
Urine color change   3/12 (25.00%)  3 0/47 (0.00%)  0 0/48 (0.00%)  0
Skin and subcutaneous tissue disorders       
Burn   1/12 (8.33%)  1 0/47 (0.00%)  0 0/48 (0.00%)  0
Indicates events were collected by systematic assessment
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. Setsuko K. Chambers
Organization: University of Arizona
Phone: 520-626-0950
EMail: schamber@uacc.arizona.edu
Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00699907    
Other Study ID Numbers: 04-0707-04
P30CA023074 ( U.S. NIH Grant/Contract )
First Submitted: June 17, 2008
First Posted: June 18, 2008
Results First Submitted: April 20, 2016
Results First Posted: January 5, 2018
Last Update Posted: July 24, 2018