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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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
Hartford, Connecticut, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States
Woman's Hospital
Baton Rouge, Louisiana, United States
Maine Medical Center - Bramhall Campus
Portland, Maine, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Freeman Cancer Institute at Freeman Health System
Joplin, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
...and 12 more locations
Progression-free Survival at 6 Months
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.
Time frame: 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.
Proportion of Patients With Objective Tumor Response
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.
Time frame: 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.
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time frame: Every cycle, during treatment (average of 3 months).
Progression-free Survival
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.
Time frame: 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.
Overall Survival
Time frame: Five years
Progression-free Survival by Platinum Sensitivity
Platinum Senstive defined as treatment free interval \>6 months on most recent platinum
Time frame: 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 Performance Status
Time frame: 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)
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.
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Time frame: 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.