Ovarian Cancer Clinical Trial
Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Summary
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.
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
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There are 22 Locations for this study
Los Angeles California, 90027, United States
Hartford Connecticut, 06105, United States
New Britain Connecticut, 06050, United States
Hinsdale Illinois, 60521, United States
Baton Rouge Louisiana, 70815, United States
Portland Maine, 04102, United States
Pascagoula Mississippi, 39581, United States
Joplin Missouri, 64804, United States
Springfield Missouri, 65807, United States
Omaha Nebraska, 68114, United States
Voorhees New Jersey, 08043, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43214, United States
Mentor Ohio, 44060, United States
Oklahoma City Oklahoma, 73104, United States
Abington Pennsylvania, 19001, United States
Bryn Mawr Pennsylvania, 19010, United States
Paoli Pennsylvania, 19301, United States
Wynnewood Pennsylvania, 19096, United States
Providence Rhode Island, 02905, United States
Galveston Texas, 77555, United States
Marshfield Wisconsin, 54449, United States
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