A Phase II Evaluation of Mifepristone in the Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with progression-free survival for at least 6 months
No
Thomas F. Rocereto, MD
Study Chair
Cancer Institute of New Jersey at Cooper - Voorhees
United States: Federal Government
CDR0000539243
NCT00459290
May 2007
Name | Location |
---|---|
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Kaiser Permanente Medical Center - Los Angeles | Los Angeles, California 90027 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Maine Medical Center - Bramhall Campus | Portland, Maine 04102 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Woman's Hospital | Baton Rouge, Louisiana 70815 |
Freeman Cancer Institute at Freeman Health System | Joplin, Missouri 64803-2644 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |