Trials / Completed
CompletedNCT00459290
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Gynecologic Oncology Group · Network
- Sex
- Female
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mifepristone |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2010-07-01
- Completion
- 2010-07-01
- First posted
- 2007-04-11
- Last updated
- 2018-07-18
- Results posted
- 2014-06-18
Locations
22 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00459290. Inclusion in this directory is not an endorsement.