Ovarian Cancer Clinical Trial
Official title:
A Phase II Evaluation of Mifepristone in the Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma
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.
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.
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