A Study of Letrozole in the Treatment of Endometrial Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Currently available treatments for endometrial cancer are associated with limited efficacy and significant toxicity. This study will assess the safety and efficacy of letrozole, an aromatase inhibitor, on endometrial cancer.
Response rates (complete response, partial response, no change, progressive disease) measured by tumor marker assessments and radiologic imaging at week 12 then every 12 weeks x 1 year followed by every 16 weeks
Secondary Outcome Measures :
Duration of clinical response, time to progression of the disease, correlation of tumor response with pretreatment ER/PR status, histological grade and aromatase levels
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Postmenopausal women with recurrent or metastatic adeno- or adenosquamous carcinoma of the endometrium
No adjuvant therapy
Up to one prior hormonal (progestin) therapy for advanced/metastatic disease allowed
No chemotherapy for recurrence (adjuvant permitted)
Unidimensionally measurable disease
Good Health status 0-2 (Eastern Cooperatitve Oncology Group)
No prior tamoxifen or aromatase inhibitor therapy
No other concurrent anti-cancer treatment
No metastases in the central nervous system
Additional protocol-defined inclusion/exclusion criteria may apply