NCT00004251

Letrozole in Treating Women With Recurrent or Metastatic Endometrial Cancer

A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	letrozole	2.5 mg of letrozole per day

Timeline

• Start date: 2000-01-19
• Primary completion: 2002-09-13
• Completion: 2011-01-18
• First posted: 2004-06-17
• Last updated: 2020-04-06