Letrozole in Treating Women With Recurrent or Metastatic Endometrial Cancer
- Registration Number
- NCT00004251
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Letrozole letrozole Letrozole 2.5 mg po daily
- Primary Outcome Measures
Name Time Method Objective tumour response 3 years
- Secondary Outcome Measures
Name Time Method tumour response 3 years Correlation of tumour response with pre-treatment ER/PR status, histological grade and aromatase levels.
toxicity 3 years duration of response and time to progression 3 years