Letrozole in Treating Women With Recurrent or Metastatic Endometrial Cancer
|ClinicalTrials.gov Identifier: NCT00004251|
Recruitment Status : Completed
First Posted : June 17, 2004
Last Update Posted : September 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: letrozole||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer|
|Study Start Date :||January 2000|
|Actual Primary Completion Date :||September 2002|
|Actual Study Completion Date :||January 2011|
Letrozole 2.5 mg po daily
2.5 mg of letrozole per day
- Objective tumour response [ Time Frame: 3 years ]
- duration of response and time to progression [ Time Frame: 3 years ]
- toxicity [ Time Frame: 3 years ]
- tumour response [ Time Frame: 3 years ]Correlation of tumour response with pre-treatment ER/PR status, histological grade and aromatase levels.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004251
|Study Chair:||Anthony Fyles, MD||Princess Margaret Hospital, Canada|