Trial Outcomes & Findings for Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT00459290)

Last Updated: 2018-07-18

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.

Results posted on

2018-07-18

Participant Flow

The study was activated on 5/7/2007 and closed to accrual on 10/29/2007.

Participant milestones

Participant milestones
Measure	Mifepristone Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
Overall Study STARTED	24
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Mifepristone Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
Overall Study Adverse Event	3
Overall Study Ineligible	2

Baseline Characteristics

Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mifepristone n=22 Participants Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
Age, Customized 40-49 years	1 participants n=99 Participants
Age, Customized 50-59 years	6 participants n=99 Participants
Age, Customized 60-69 years	8 participants n=99 Participants
Age, Customized 70-79 years	6 participants n=99 Participants
Age, Customized 80-89 years	1 participants n=99 Participants
Sex: Female, Male Female	22 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.

Population: Eligible and treated participants

Outcome measures

Outcome measures
Measure	Mifepristone n=22 Participants Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy	Platinum Sensitive	>=70
Progression-free Survival at 6 Months	13.6 percentage of participants Interval 2.9 to 34.9	—	—

PRIMARY outcome

Population: Eligible and treated participants

Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.

Outcome measures

Outcome measures
Measure	Mifepristone n=22 Participants Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy	Platinum Sensitive	>=70
Proportion of Patients With Objective Tumor Response	4.5 percentage of participants Interval 0.1 to 22.8	—	—

PRIMARY outcome

Timeframe: Every cycle, during treatment (average of 3 months).

Population: Eligible and treated patients

Outcome measures

Outcome measures
Measure	Mifepristone n=22 Participants Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy	Platinum Sensitive	>=70
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Anemia	1 Participants	—	—
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Coagulation	2 Participants	—	—
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Dermatologic	1 Participants	—	—
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Gastrointestinal	1 Participants	—	—
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Hemorrhage	1 Participants	—	—

SECONDARY outcome

Population: Eligible and treated participants

Outcome measures

Outcome measures
Measure	Mifepristone n=22 Participants Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy	Platinum Sensitive	>=70
Progression-free Survival	1.8 months Interval 1.7 to 3.2	—	—

SECONDARY outcome

Timeframe: Five years

Population: Eligible and treated participants

Outcome measures

Outcome measures
Measure	Mifepristone n=22 Participants Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy	Platinum Sensitive	>=70
Overall Survival	NA months Interval 7.5 to NA (not available): insufficient number of participants with events.	—	—

SECONDARY outcome

Population: Eligible and treated participants with treatment free interval available

Platinum Senstive defined as treatment free interval \>6 months on most recent platinum

Outcome measures

Outcome measures
Measure	Mifepristone n=13 Participants Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy	Platinum Sensitive n=8 Participants	>=70
Progression-free Survival by Platinum Sensitivity	1.7 months Interval 1.7 to 3.8	1.9 months Interval 1.1 to 4.2	—

SECONDARY outcome

Population: Eligible and treated participants

Outcome measures

Outcome measures
Measure	Mifepristone n=13 Participants Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy	Platinum Sensitive n=9 Participants	>=70
Progression-free Survival by Performance Status	1.8 months Interval 1.7 to 4.1	1.7 months Interval 0.9 to 3.2	—

SECONDARY outcome

Population: Eligible and treated participants

Outcome measures

Outcome measures
Measure	Mifepristone n=7 Participants Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy	Platinum Sensitive n=8 Participants	>=70 n=7 Participants
Progression-free Survival by Age (y)	1.7 months Interval 0.9 to 2.4	4.0 months Interval 1.6 to 8.1	1.7 months Interval 1.1 to 1.8

Adverse Events

Mifepristone

Serious events: 8 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mifepristone n=22 participants at risk Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
General disorders Death No Ctcae Term - Disease Progression Nos	4.5% 1/22 • every cycle during treatment
Gastrointestinal disorders Perforation, Gi - Colon	4.5% 1/22 • every cycle during treatment
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	9.1% 2/22 • every cycle during treatment
General disorders Pain: Abdominal Pain Nos	4.5% 1/22 • every cycle during treatment
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.5% 1/22 • every cycle during treatment
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 2/22 • every cycle during treatment

Other adverse events

Other adverse events
Measure	Mifepristone n=22 participants at risk Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
Blood and lymphatic system disorders Neutrophils	4.5% 1/22 • every cycle during treatment
Blood and lymphatic system disorders Platelets	9.1% 2/22 • every cycle during treatment
Blood and lymphatic system disorders Leukocytes	13.6% 3/22 • every cycle during treatment
Blood and lymphatic system disorders Hemoglobin	31.8% 7/22 • every cycle during treatment
Vascular disorders Inr	9.1% 2/22 • every cycle during treatment
General disorders Fatigue	40.9% 9/22 • every cycle during treatment
Skin and subcutaneous tissue disorders Hair Loss/Alopecia (Scalp Or Body)	4.5% 1/22 • every cycle during treatment
Skin and subcutaneous tissue disorders Rash	9.1% 2/22 • every cycle during treatment
Skin and subcutaneous tissue disorders Pruritus	9.1% 2/22 • every cycle during treatment
Endocrine disorders Hot Flashes	18.2% 4/22 • every cycle during treatment
Gastrointestinal disorders Flatulence	9.1% 2/22 • every cycle during treatment
Gastrointestinal disorders Gastritis	4.5% 1/22 • every cycle during treatment
Gastrointestinal disorders Heartburn	9.1% 2/22 • every cycle during treatment
Gastrointestinal disorders Ascites	9.1% 2/22 • every cycle during treatment
Gastrointestinal disorders Distention	4.5% 1/22 • every cycle during treatment
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	4.5% 1/22 • every cycle during treatment
Gastrointestinal disorders Vomiting	27.3% 6/22 • every cycle during treatment
Gastrointestinal disorders Anorexia	13.6% 3/22 • every cycle during treatment
Gastrointestinal disorders Dehydration	13.6% 3/22 • every cycle during treatment
Gastrointestinal disorders Constipation	22.7% 5/22 • every cycle during treatment
Gastrointestinal disorders Nausea	54.5% 12/22 • every cycle during treatment
Gastrointestinal disorders Diarrhea	13.6% 3/22 • every cycle during treatment
Vascular disorders Hemorrhage, Gu - Urinary Nos	9.1% 2/22 • every cycle during treatment
Vascular disorders Hemorrhage, Gi - Rectum	4.5% 1/22 • every cycle during treatment
Vascular disorders Hemorrhage, Gu - Bladder	4.5% 1/22 • every cycle during treatment
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	13.6% 3/22 • every cycle during treatment
Infections and infestations Inf Unknown Anc: Urinary Tract Nos	4.5% 1/22 • every cycle during treatment
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	4.5% 1/22 • every cycle during treatment
Metabolism and nutrition disorders Ast	4.5% 1/22 • every cycle during treatment
Metabolism and nutrition disorders Creatinine	9.1% 2/22 • every cycle during treatment
Metabolism and nutrition disorders Hypoalbuminemia	13.6% 3/22 • every cycle during treatment
Metabolism and nutrition disorders Bilirubin	4.5% 1/22 • every cycle during treatment
Metabolism and nutrition disorders Hypophosphatemia	9.1% 2/22 • every cycle during treatment
Metabolism and nutrition disorders Hyponatremia	4.5% 1/22 • every cycle during treatment
Metabolism and nutrition disorders Hypocalcemia	13.6% 3/22 • every cycle during treatment
Metabolism and nutrition disorders Hyperkalemia	4.5% 1/22 • every cycle during treatment
Metabolism and nutrition disorders Hyperglycemia	18.2% 4/22 • every cycle during treatment
Metabolism and nutrition disorders Hypokalemia	22.7% 5/22 • every cycle during treatment
Metabolism and nutrition disorders Hypoglycemia	9.1% 2/22 • every cycle during treatment
Metabolism and nutrition disorders Hypomagnesemia	9.1% 2/22 • every cycle during treatment
Musculoskeletal and connective tissue disorders Arthritis	4.5% 1/22 • every cycle during treatment
Musculoskeletal and connective tissue disorders Muscle Weakness - Whole Body/Generalized	4.5% 1/22 • every cycle during treatment
Musculoskeletal and connective tissue disorders Muscle Weakness - Extremity-Lower	4.5% 1/22 • every cycle during treatment
Nervous system disorders Mood Alteration - Depression	4.5% 1/22 • every cycle during treatment
Nervous system disorders Mood Alteration - Anxiety	4.5% 1/22 • every cycle during treatment
Nervous system disorders Irritability	4.5% 1/22 • every cycle during treatment
Nervous system disorders Neuropathy-Sensory	13.6% 3/22 • every cycle during treatment
Nervous system disorders Neuropathy-Motor	4.5% 1/22 • every cycle during treatment
Eye disorders Blurred Vision	9.1% 2/22 • every cycle during treatment
General disorders Pain: Pelvis	4.5% 1/22 • every cycle during treatment
General disorders Pain: Pleura	4.5% 1/22 • every cycle during treatment
General disorders Pain: Extremity-Limb	4.5% 1/22 • every cycle during treatment
General disorders Pain: Back	4.5% 1/22 • every cycle during treatment
General disorders Pain: Joint	4.5% 1/22 • every cycle during treatment
General disorders Pain: Bladder	4.5% 1/22 • every cycle during treatment
General disorders Pain: Abdominal Pain Nos	31.8% 7/22 • every cycle during treatment
General disorders Pain: Tumor	4.5% 1/22 • every cycle during treatment
General disorders Pain: Muscle	4.5% 1/22 • every cycle during treatment
Respiratory, thoracic and mediastinal disorders Hypoxia	4.5% 1/22 • every cycle during treatment
Respiratory, thoracic and mediastinal disorders Dyspnea	13.6% 3/22 • every cycle during treatment
Renal and urinary disorders Urinary Frequency	9.1% 2/22 • every cycle during treatment
Vascular disorders Thrombosis/Thrombus/Embolism	4.5% 1/22 • every cycle during treatment

Additional Information

Jessalyn Reboy

Gynecologic Oncology Group Statistical and Data Center

Phone: 716-845-7738

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place