A Study of Letrozole in the Treatment of Endometrial Cancer

This study has been completed.
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00333086
First received: June 1, 2006
Last updated: April 18, 2012
Last verified: April 2012

June 1, 2006
April 18, 2012
January 2000
June 2006   (final data collection date for primary 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
Same as current
Complete list of historical versions of study NCT00333086 on ClinicalTrials.gov Archive Site
Duration of clinical response, time to progression of the disease, correlation of tumor response with pretreatment ER/PR status, histological grade and aromatase levels
Same as current
Not Provided
Not Provided
 
A Study of Letrozole in the Treatment of Endometrial Cancer
A PHASE II STUDY OF LETROZOLE IN PATIENTS WITH ADVANCED OR RECURRENT ENDOMETRIAL CANCER

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Recurrent and Metastatic Endometrial Cancer
Drug: Letrozole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Not Provided
June 2006   (final data collection date for primary outcome measure)

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

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00333086
CFEM345ADE03
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
NCIC Clinical Trials Group
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP