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Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer

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ClinicalTrials.gov Identifier: NCT00617188
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : March 17, 2010
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Intervention Drug: Fulvestrant
Enrollment 26
Recruitment Details  
Pre-assignment Details 3 additional patients were enrolled, but were never treated.
Arm/Group Title Fulvestrant Treatment
Hide Arm/Group Description Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
Period Title: Overall Study
Started 26
Completed 26
Not Completed 0
Arm/Group Title Fulvestrant Treatment
Hide Arm/Group Description Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  53.8%
>=65 years
12
  46.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
26
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
1.Primary Outcome
Title Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Best response recorded from the start of treatment until Day 90. Defined by the sum of the Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=disappearance of all lesions, PR=>or =30% decrease in sum of all target lesions, Progressive Disease (PD) =>or=20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.
Time Frame Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fulvestrant Treatment
Hide Arm/Group Description:
Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: Participants
Stable Disease 8
Progressive Disease (>=20% increase/new lesions) 18
2.Secondary Outcome
Title Patients' Overall 90-Day Clinical Response as Measured by Modified Response Evaluation Criteria in Solid Tumors (Rustin)
Hide Description Defined by the sum of Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=normalization of serum CA-125 level from 2 initially elevated samples, PR=>or=50% decrease in serum CA-125 level from 2 initially elevated samples, Progressive Disease (PD)=CA-125 two times the upper limit of normal on 2 occasions (if previously normalized) OR CA-125 two times nadir (lowest value) on 2 occasions if elevated at initiation of treatment, SD=not CR, PR or PD.
Time Frame Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fulvestrant Treatment
Hide Arm/Group Description:
Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: Participants
Stable Disease 13
Progressive Disease (>= 20% increase/new lesions) 13
3.Secondary Outcome
Title Median Number of Days to Treatment Termination
Hide Description Time is determined from first dose to termination due to all causes.
Time Frame Up to 373 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fulvestrant Treatment
Hide Arm/Group Description:
Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
Overall Number of Participants Analyzed 26
Median (Full Range)
Unit of Measure: Days
62
(5 to 373)
4.Secondary Outcome
Title Mean Scores - Quality of Life Assessment
Hide Description Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O)Version 1/23/07 - This is a relative quality of life assessment; 100 = Best, 0 = Worst. It was developed and validated with cancer patients and includes physical well being, social well being, emotional well being and relationship with doctor subscales and can be summed into one total quality of life score. It is a standardized scale which collects data (scores 1-4) from 47 questions. Answers are transformed into a number between 0-100. Mean was calculated by adding up the values of the scores and dividing by the number of scores.
Time Frame Baseline, 3 Months Post Treatment, 6 Months Post Treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fulvestrant Treatment
Hide Arm/Group Description:
Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
Overall Number of Participants Analyzed 26
Mean (Full Range)
Unit of Measure: Scores on a Scale
Baseline (rounded to nearest whole number)
87
(53 to 108)
3 Months (rounded to nearest whole number)
84
(63 to 100)
6 Months (rounded to nearest whole number)
81
(79 to 96)
5.Secondary Outcome
Title Serum Skeletal-Specific Alkaline Phosphatase Concentration
Hide Description Median Bone mineral results - assessed by serum skeletal-specific alkaline phosphatase laboratory results collected from patients in study.
Time Frame Baseline, 1 Month, 3 Months, 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fulvestrant Treatment
Hide Arm/Group Description:
Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
Overall Number of Participants Analyzed 26
Median (Full Range)
Unit of Measure: Units/Liter
Alkaline Phosphatase levels - Baseline
14.0
(6.9 to 23.5)
Alkaline Phosphatase levels - 1 Month
16.1
(7.1 to 26.5)
Alkaline Phosphase levels - 3 Months
18.5
(8.3 to 25.5)
Alkaline Phosphase levels - 6 Months
16.2
(13.8 to 29.2)
6.Secondary Outcome
Title Urine N-telopeptide Concentration
Hide Description Median bone mineral results - assessed by serial urine N-telopeptide laboratory results collected from patients.
Time Frame Baseline, 1 Month, 3 Months, 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fulvestrant Treatment
Hide Arm/Group Description:
Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
Overall Number of Participants Analyzed 26
Median (Full Range)
Unit of Measure: Units of Bone Collagen Equivalents/mmol
Urinary N-telopeptide level - Baseline
50
(8 to 184)
Urinary N-telopeptide level - 1 Month
49
(11 to 117)
Urinary N-telopeptide level - 3 Months
43
(18 to 115)
Urinary N-telopeptide level - 6 Months
46
(42 to 91)
Time Frame Through 30 days after last treatment with Fulvestrant.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fulvestrant Treatment
Hide Arm/Group Description Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
All-Cause Mortality
Fulvestrant Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fulvestrant Treatment
Affected / at Risk (%) # Events
Total   10/26 (38.46%)    
Cardiac disorders   
Pericardial effusion (non-malignant)  1  1/26 (3.85%)  1
Gastrointestinal disorders   
Bowel obstruction, non-specific  1  3/26 (11.54%)  3
Nausea  1  1/26 (3.85%)  1
Vomiting  1  1/26 (3.85%)  1
General disorders   
Death, non-specific  1  2/26 (7.69%)  2
Failure to thrive  1  1/26 (3.85%)  1
Pain  1  1/26 (3.85%)  1
Pain, abdomen  1  1/26 (3.85%)  1
Musculoskeletal and connective tissue disorders   
Fracture  1  1/26 (3.85%)  1
Respiratory, thoracic and mediastinal disorders   
Ascites (non-malignant)  1  1/26 (3.85%)  1
Pleural effusion (non-malignant)  1  2/26 (7.69%)  2
Indicates events were collected by 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 4%
Fulvestrant Treatment
Affected / at Risk (%) # Events
Total   2/26 (7.69%)    
Nervous system disorders   
Headache  1 [1]  1/26 (3.85%)  1
Skin and subcutaneous tissue disorders   
Bromidrosis  1 [2]  2/26 (7.69%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Mild
[2]
Mild, foul smelling perspiration
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Peter Argenta, M.D.
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-626-6037
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00617188     History of Changes
Other Study ID Numbers: CDR0000582821
UMN-2007LS003 ( Other Identifier: Clinical Trials Office, University of Minnesota )
UMN-WCC-49 ( Other Identifier: Women's Cancer Center, University of Minnesota )
UMN-0612M97626 ( Other Identifier: IRB, University of Minnesota )
IRUSFULV0062 ( Other Identifier: AstraZeneca )
First Submitted: February 14, 2008
First Posted: February 15, 2008
Results First Submitted: June 12, 2009
Results First Posted: March 17, 2010
Last Update Posted: December 28, 2017