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