Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, 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.

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