Back to resultsA Study of Letrozole in the Treatment of Endometrial Cancer
Primary Purpose
Recurrent and Metastatic Endometrial Cancer
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Letrozole
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent and Metastatic Endometrial Cancer focused on measuring Endometrial Cancer, Aromatase inhibitor, Letrozole
Eligibility 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
Sites / Locations
- Novartis Investigative Site
Outcomes
Primary Outcome Measures
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
Full Information
NCT ID
NCT00333086
First Posted
June 1, 2006
Last Updated
April 18, 2012
Sponsor
Novartis Pharmaceuticals
Collaborators
Canadian Cancer Trials Group
1. Study Identification
Unique Protocol Identification Number
NCT00333086
Brief Title
A Study of Letrozole in the Treatment of Endometrial Cancer
Official Title
A PHASE II STUDY OF LETROZOLE IN PATIENTS WITH ADVANCED OR RECURRENT ENDOMETRIAL CANCER
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
Canadian Cancer Trials Group
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent and Metastatic Endometrial Cancer
Keywords
Endometrial Cancer, Aromatase inhibitor, Letrozole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Letrozole
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Duration of clinical response, time to progression of the disease, correlation of tumor response with pretreatment ER/PR status, histological grade and aromatase levels
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Heidelberg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study of Letrozole in the Treatment of Endometrial Cancer
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