Trial Outcomes & Findings for Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer (NCT NCT00617188)

NCT ID: NCT00617188

Last Updated: 2017-12-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 26 participants
• Primary outcome timeframe: Day 90
• Results posted on: 2017-12-28

Participant Flow

3 additional patients were enrolled, but were never treated.

Participant milestones

Measure	Fulvestrant Treatment 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 Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer

Baseline characteristics by cohort

Measure	Fulvestrant Treatment n=26 Participants 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)
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants
Age, Categorical >=65 years	12 Participants n=93 Participants
Sex: Female, Male Female	26 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	26 participants n=93 Participants

PRIMARY outcome

Timeframe: Day 90

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.

Outcome measures

Measure	Fulvestrant Treatment n=26 Participants 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)
Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Stable Disease	8 Participants
Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Progressive Disease (>=20% increase/new lesions)	18 Participants

SECONDARY outcome

Timeframe: Day 90

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.

Outcome measures

Measure	Fulvestrant Treatment n=26 Participants 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)
Patients' Overall 90-Day Clinical Response as Measured by Modified Response Evaluation Criteria in Solid Tumors (Rustin) Stable Disease	13 Participants
Patients' Overall 90-Day Clinical Response as Measured by Modified Response Evaluation Criteria in Solid Tumors (Rustin) Progressive Disease (>= 20% increase/new lesions)	13 Participants

SECONDARY outcome

Timeframe: Up to 373 Days

Time is determined from first dose to termination due to all causes.

Outcome measures

Measure	Fulvestrant Treatment n=26 Participants 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)
Median Number of Days to Treatment Termination	62 Days Interval 5.0 to 373.0

SECONDARY outcome

Timeframe: Baseline, 3 Months Post Treatment, 6 Months Post Treatment

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.

Outcome measures

Measure	Fulvestrant Treatment n=26 Participants 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)
Mean Scores - Quality of Life Assessment Baseline (rounded to nearest whole number)	87 Scores on a Scale Interval 53.0 to 108.0
Mean Scores - Quality of Life Assessment 3 Months (rounded to nearest whole number)	84 Scores on a Scale Interval 63.0 to 100.0
Mean Scores - Quality of Life Assessment 6 Months (rounded to nearest whole number)	81 Scores on a Scale Interval 79.0 to 96.0

SECONDARY outcome

Timeframe: Baseline, 1 Month, 3 Months, 6 Months

Median Bone mineral results - assessed by serum skeletal-specific alkaline phosphatase laboratory results collected from patients in study.

Outcome measures

Measure	Fulvestrant Treatment n=26 Participants 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)
Serum Skeletal-Specific Alkaline Phosphatase Concentration Alkaline Phosphatase levels - Baseline	14.0 Units/Liter Interval 6.9 to 23.5
Serum Skeletal-Specific Alkaline Phosphatase Concentration Alkaline Phosphatase levels - 1 Month	16.1 Units/Liter Interval 7.1 to 26.5
Serum Skeletal-Specific Alkaline Phosphatase Concentration Alkaline Phosphase levels - 3 Months	18.5 Units/Liter Interval 8.3 to 25.5
Serum Skeletal-Specific Alkaline Phosphatase Concentration Alkaline Phosphase levels - 6 Months	16.2 Units/Liter Interval 13.8 to 29.2

SECONDARY outcome

Timeframe: Baseline, 1 Month, 3 Months, 6 Months

Median bone mineral results - assessed by serial urine N-telopeptide laboratory results collected from patients.

Outcome measures

Measure	Fulvestrant Treatment n=26 Participants 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)
Urine N-telopeptide Concentration Urinary N-telopeptide level - Baseline	50 Units of Bone Collagen Equivalents/mmol Interval 8.0 to 184.0
Urine N-telopeptide Concentration Urinary N-telopeptide level - 1 Month	49 Units of Bone Collagen Equivalents/mmol Interval 11.0 to 117.0
Urine N-telopeptide Concentration Urinary N-telopeptide level - 3 Months	43 Units of Bone Collagen Equivalents/mmol Interval 18.0 to 115.0
Urine N-telopeptide Concentration Urinary N-telopeptide level - 6 Months	46 Units of Bone Collagen Equivalents/mmol Interval 42.0 to 91.0

Adverse Events

Fulvestrant Treatment

Serious events: 10 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fulvestrant Treatment n=26 participants at risk 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)
Respiratory, thoracic and mediastinal disorders Ascites (non-malignant)	3.8% 1/26 • Number of events 1 • Through 30 days after last treatment with Fulvestrant.
Gastrointestinal disorders Bowel obstruction, non-specific	11.5% 3/26 • Number of events 3 • Through 30 days after last treatment with Fulvestrant.
General disorders Death, non-specific	7.7% 2/26 • Number of events 2 • Through 30 days after last treatment with Fulvestrant.
General disorders Failure to thrive	3.8% 1/26 • Number of events 1 • Through 30 days after last treatment with Fulvestrant.
Musculoskeletal and connective tissue disorders Fracture	3.8% 1/26 • Number of events 1 • Through 30 days after last treatment with Fulvestrant.
Gastrointestinal disorders Nausea	3.8% 1/26 • Number of events 1 • Through 30 days after last treatment with Fulvestrant.
General disorders Pain	3.8% 1/26 • Number of events 1 • Through 30 days after last treatment with Fulvestrant.
General disorders Pain, abdomen	3.8% 1/26 • Number of events 1 • Through 30 days after last treatment with Fulvestrant.
Cardiac disorders Pericardial effusion (non-malignant)	3.8% 1/26 • Number of events 1 • Through 30 days after last treatment with Fulvestrant.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	7.7% 2/26 • Number of events 2 • Through 30 days after last treatment with Fulvestrant.
Gastrointestinal disorders Vomiting	3.8% 1/26 • Number of events 1 • Through 30 days after last treatment with Fulvestrant.

Other adverse events

Measure	Fulvestrant Treatment n=26 participants at risk 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)
Skin and subcutaneous tissue disorders Bromidrosis	7.7% 2/26 • Number of events 2 • Through 30 days after last treatment with Fulvestrant.
Nervous system disorders Headache	3.8% 1/26 • Number of events 1 • Through 30 days after last treatment with Fulvestrant.

Additional Information

Peter Argenta, M.D.

Masonic Cancer Center, University of Minnesota

Phone: 612-626-6037

Email: argenta@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place