Clinical trial · Interventional
Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
A Phase II Evaluation of Mifepristone in the Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mifepristone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mifepristone 200 mg PO daily
- 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.
- interventionNames
- Drug: mifepristone
Primary outcomes (3)
- measure
- Progression-free Survival at 6 Months
- timeFrame
- Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.
- description
- Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 mifepristoneReferences
Publications (1)
- RESULTRocereto TF, Brady WE, Shahin MS, Hoffman JS, Small L, Rotmensch J, Mannel RS. A phase II evaluation of mifepristone in the treatment of recurrent or persistent epithelial ovarian, fallopian or primary peritoneal cancer: a gynecologic oncology group study. Gynecol Oncol. 2010 Mar;116(3):332-4. doi: 10.1016/j.ygyno.2009.10.071. Epub 2009 Nov 17. PMID 19922989