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

Phase 2

Completed

Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer

Interventions: Drug: mifepristone

Registration Number: NCT00459290

Lead Sponsor: Gynecologic Oncology Group

Brief Summary: RATIONALE: Progesterone can cause the growth of ovarian epithelial cancer , primary peritoneal cancer, or fallopian tube cancer. Hormone therapy using mifepristone may fight ovarian epithelial cancer and primary peritoneal cancer by lowering the amount of progesterone the body makes.

PURPOSE: This phase II trial is studying the side effects and how well mifepristone works in treating patients with recurrent or persistent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

Detailed Description: OBJECTIVES:

Primary

* Determine the antitumor activity of mifepristone in patients with recurrent or persistent ovarian epithelial, primary peritoneal, or fallopian tube carcinoma.

* Determine the toxicity of this drug in these patients.

Secondary

* Determine the duration of progression-free survival and overall survival of patients treated with this drug.

* Determine the potential impact of platinum sensitivity, initial performance status, and age on prognosis in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral mifepristone once daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mifepristone 200 mg PO daily	mifepristone	Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks is considered one cycle) until disease progression or adverse effects prohibit further therapy.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival at 6 Months	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.	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.
Proportion of Patients With Objective Tumor Response	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.	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.
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Every cycle, during treatment (average of 3 months).

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	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.	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.
Overall Survival	Five years
Progression-free Survival by Platinum Sensitivity	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.	Platinum Senstive defined as treatment free interval \>6 months on most recent platinum
Progression-free Survival by Performance Status	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.
Progression-free Survival by Age (y)	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.	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.

Trial Locations

Locations (22): Kaiser Permanente Medical Center - Los Angeles
🇺🇸
Los Angeles, California, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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Hartford, Connecticut, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
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New Britain, Connecticut, United States
Hinsdale Hematology Oncology Associates
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Hinsdale, Illinois, United States
Woman's Hospital
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Baton Rouge, Louisiana, United States
Maine Medical Center - Bramhall Campus
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Portland, Maine, United States
Regional Cancer Center at Singing River Hospital
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Pascagoula, Mississippi, United States
Freeman Cancer Institute at Freeman Health System
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Joplin, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
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Springfield, Missouri, United States
Methodist Estabrook Cancer Center
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Omaha, Nebraska, United States
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Kaiser Permanente Medical Center - Los Angeles
🇺🇸Los Angeles, California, United States