Trial Information
A PHASE II STUDY OF LETROZOLE IN PATIENTS WITH ADVANCED OR RECURRENT ENDOMETRIAL CANCER
Inclusion Criteria
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/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CFEM345ADE03
NCT ID:
NCT00333086
Start Date:
January 2000
Completion Date:
Related Keywords:
- Recurrent and Metastatic Endometrial Cancer
- Endometrial Cancer
- Aromatase inhibitor
- Letrozole
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Adenoma