Raloxifene in Treating Patients With Persistent or Recurrent Endometrial Cancer
RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy using raloxifene may fight endometrial cancer by reducing the production of estrogen.
PURPOSE: Phase II trial to study the effectiveness of raloxifene in treating patients who have persistent or recurrent endometrial cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Raloxifene in Recurrent Endometrial Cancer|
|Study Start Date:||November 1998|
|Study Completion Date:||February 2000|
|Primary Completion Date:||February 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine response rate and time to disease progression in patients with recurrent endometrial cancer treated with raloxifene. II. Determine overall survival in these patients treated with this regimen. III. Determine the toxicity of raloxifene in this patient population.
OUTLINE: Patients receive oral raloxifene daily. Treatment continues indefinitely in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 13-50 patients will be accrued for this study within 2.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004915
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611|
|Study Chair:||Phillip Y. Roland, MD||Florida Gynecologic Oncology - Fort Myers|