Recurrent and Metastatic Endometrial Cancer
Conditions
Keywords
Endometrial Cancer, Aromatase inhibitor, Letrozole
Brief summary
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.
Interventions
DRUGLetrozole
Sponsors
Canadian Cancer Trials Group
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
Additional protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Duration of clinical response, time to progression of the disease, correlation of tumor response with pretreatment ER/PR status, histological grade and aromatase levels | — |
Countries
Germany
Outcome results
None listed