Clinical trial NCT00459290 (phase 2, status: completed)
Conditions: fallopian tube cancer, ovarian cancer, primary peritoneal cavity cancer
ICD codes: C57.00, C57.01, C57.02, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C30.0, Z12.81, D14.0, C14.8, D37.09, Z86.003, Z85.818
Drugs: mifepristone
SMILES: CO[C@H]1\C=C\O[C@@]2(C)OC3=C(C2=O)C2=C(O)C(\C=N\N4CCN(C)CC4)=C(NC(=O)\C(C)=C/C=C/[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@@H]1C)C(O)=C2C(O)=C3C
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