Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Mifepristone in the Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma|
- Proportion of patients with progression-free survival for at least 6 months [ Designated as safety issue: No ]
- Proportion of patients with objective tumor response [ Designated as safety issue: No ]
- Frequency and severity of toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Duration of progression-free survival [ Designated as safety issue: No ]
- Duration of overall survival [ Designated as safety issue: No ]
- Prognostic potential of platinum sensitivity, initial performance status, and age [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Show 22 Study Locations
|Study Chair:||Thomas F. Rocereto, MD||Cancer Institute of New Jersey at Cooper - Voorhees|
|Investigator:||Leslie R. DeMars, MD||Norris Cotton Cancer Center|