- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00459290
Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
A Phase II Evaluation of Mifepristone in the Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90027
- Kaiser Permanente Medical Center - Los Angeles
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Connecticut
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Hartford, Connecticut, United States, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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New Britain, Connecticut, United States, 06050
- George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
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Illinois
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Hinsdale, Illinois, United States, 60521
- Hinsdale Hematology Oncology Associates
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Louisiana
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Baton Rouge, Louisiana, United States, 70815
- Woman's Hospital
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Maine
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Portland, Maine, United States, 04102
- Maine Medical Center - Bramhall Campus
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Mississippi
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Pascagoula, Mississippi, United States, 39581
- Regional Cancer Center at Singing River Hospital
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Missouri
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Joplin, Missouri, United States, 64804
- Freeman Cancer Institute at Freeman Health System
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Springfield, Missouri, United States, 65807
- Hulston Cancer Center at Cox Medical Center South
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Nebraska
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Omaha, Nebraska, United States, 68114
- Methodist Estabrook Cancer Center
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New Jersey
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Voorhees, New Jersey, United States, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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Ohio
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Cleveland, Ohio, United States, 44106-5065
- Case Comprehensive Cancer Center
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Columbus, Ohio, United States, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Mentor, Ohio, United States, 44060
- Lake/University Ireland Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma University Cancer Institute
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Pennsylvania
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Abington, Pennsylvania, United States, 19001
- Rosenfeld Cancer Center at Abington Memorial Hospital
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Bryn Mawr, Pennsylvania, United States, 19010
- Bryn Mawr Hospital
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Paoli, Pennsylvania, United States, 19301-1792
- Cancer Center of Paoli Memorial Hospital
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Wynnewood, Pennsylvania, United States, 19096
- Lankenau Cancer Center at Lankenau Hospital
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Rhode Island
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Providence, Rhode Island, United States, 02905
- Women and Infants Hospital of Rhode Island
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Texas
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Galveston, Texas, United States, 77555-0361
- University of Texas Medical Branch
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic - Marshfield Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube carcinoma*
- Recurrent or refractory disease NOTE: *Histological confirmation of original primary tumor required
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, and MRI OR ≥ 10 mm by spiral CT scan
Must have ≥ 1 target lesion
- Tumors within a previously irradiated field are designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy
Prior treatment with 1 platinum-based chemotherapeutic regimen (comprising carboplatin, cisplatin, or another organoplatinum compound) for management of primary disease required
Initial treatment may have included any of the following:
- High-dose therapy
- Consolidation therapy
- Extended therapy administered after surgical or nonsurgical assessment
Patients must meet ≥ 1 of the following criteria:
- Treatment-free interval after platinum therapy of < 12 months
- Progressed during platinum-based therapy
- Persistent disease after a platinum-based regimen
- Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists
PATIENT CHARACTERISTICS:
- GOG performance status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- AST ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- No active infection requiring antibiotics
- No other invasive malignancies within the past 5 years, except non-melanoma skin cancer
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior surgery, radiotherapy, or chemotherapy
- No prior cancer treatment that would preclude protocol therapy
No prior radiotherapy to any portion of the abdominal cavity or pelvis unless for treatment of ovarian cancer
- Prior radiotherapy for localized cancer of the breast, head and neck, or skin is permitted, provided it was completed > 3 years prior to study entry and no recurrent or metastatic disease exists
No prior chemotherapy to any portion of the abdominal cavity or pelvis unless for treatment of ovarian cancer
- Prior chemotherapy for localized cancer of the breast is permitted, provided it was completed > 3 years prior to study entry and no recurrent or metastatic disease exists
- At least 1 week since prior hormonal therapy directed at the malignant tumor
- At least 2 weeks since other prior hormonal therapy (e.g., testosterone, estrogen, progestin, or gonadotropin-releasing hormone antagonists)
- At least 3 weeks since other prior therapy directed at the malignant tumor, including biological or immunologic agents
- One prior cytotoxic regimen (defined as any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa) for management of recurrent or persistent disease allowed
- No prior non-cytotoxic therapy for management of recurrent or persistent ovarian epithelial or primary peritoneal carcinoma
- No prior mifepristone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Mifepristone 200 mg PO daily
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival at 6 Months
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.
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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. |
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.
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Proportion of Patients With Objective Tumor 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.
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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. |
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.
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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).
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Every cycle, during treatment (average of 3 months).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival
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.
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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. |
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.
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Overall Survival
Time Frame: Five years
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Five years
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Progression-free Survival by Platinum Sensitivity
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.
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Platinum Senstive defined as treatment free interval >6 months on most recent platinum
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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.
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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.
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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.
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Progression-free Survival by Age (y)
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.
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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. |
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.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Thomas F. Rocereto, MD, Cancer Institute of New Jersey at Cooper - Voorhees
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Adnexal Diseases
- Fallopian Tube Diseases
- Fallopian Tube Neoplasms
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Abortifacient Agents
- Luteolytic Agents
- Abortifacient Agents, Steroidal
- Contraceptives, Postcoital, Synthetic
- Contraceptives, Postcoital
- Menstruation-Inducing Agents
- Mifepristone
Other Study ID Numbers
- GOG-0170K
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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