Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Primary Peritoneal Cavity Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: mifepristone

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00459290

GOG-0170K

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

24 participants in 1 patient group

Mifepristone 200 mg PO daily

Experimental group

Description:

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.

Treatment:

Drug: mifepristone