Letrozole in Treating Women With Recurrent or Metastatic Endometrial Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of letrozole in treating women who have recurrent or metastatic endometrial cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer|
- Objective tumour response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- duration of response and time to progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- tumour response [ Time Frame: 3 years ] [ Designated as safety issue: No ]Correlation of tumour response with pre-treatment ER/PR status, histological grade and aromatase levels.
|Study Start Date:||January 2000|
|Study Completion Date:||January 2011|
|Primary Completion Date:||September 2002 (Final data collection date for primary outcome measure)|
Letrozole 2.5 mg po daily
2.5 mg of letrozole per day
OBJECTIVES: I. Determine the efficacy of letrozole, in terms of objective tumor response and time to progression, in women with recurrent or metastatic endometrial cancer. II. Determine the toxicity of letrozole in these patients. III. Determine the relationship between tumor receptor status, histologic grade, tumor aromatase activity, and tumor response in these patients.
OUTLINE: Patients receive an oral letrozole tablet daily. Treatment continues for patients with complete or partial response until disease progression or unacceptable toxicity. Patients with stable disease may discontinue therapy after 24 weeks. Patients are followed at 1 month and then every 3 months until death.
PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study within 12-18 months.