Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms
Intervention: mifepristone
Intervention MeSH terms: Mifepristone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent ovarian epithelial cancer; primary peritoneal cavity cancer; 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.
    

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