Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer
Eligibility Criteria
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
Sites / Locations
- Kaiser Permanente Medical Center - Los Angeles
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
- Hinsdale Hematology Oncology Associates
- Woman's Hospital
- Maine Medical Center - Bramhall Campus
- Regional Cancer Center at Singing River Hospital
- Freeman Cancer Institute at Freeman Health System
- Hulston Cancer Center at Cox Medical Center South
- Methodist Estabrook Cancer Center
- Cancer Institute of New Jersey at Cooper - Voorhees
- Case Comprehensive Cancer Center
- Riverside Methodist Hospital Cancer Care
- Lake/University Ireland Cancer Center
- Oklahoma University Cancer Institute
- Rosenfeld Cancer Center at Abington Memorial Hospital
- Bryn Mawr Hospital
- Cancer Center of Paoli Memorial Hospital
- Lankenau Cancer Center at Lankenau Hospital
- Women and Infants Hospital of Rhode Island
- University of Texas Medical Branch
- Marshfield Clinic - Marshfield Center
Arms of the Study
Arm 1
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.