A Study of Letrozole in the Treatment of Endometrial Cancer

This study has been completed.

Sponsor:

Collaborator:

NCIC CTG

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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 1, 2006

Last Updated Date

April 18, 2012

Start Date ^ICMJE

January 2000

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00333086 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of clinical response, time to progression of the disease, correlation of tumor response with pretreatment ER/PR status, histological grade and aromatase levels

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Letrozole in the Treatment of Endometrial Cancer

Official Title ^ICMJE

A PHASE II STUDY OF LETROZOLE IN PATIENTS WITH ADVANCED OR RECURRENT ENDOMETRIAL CANCER

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Recurrent and Metastatic Endometrial Cancer

Intervention ^ICMJE

Drug: Letrozole

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00333086

Other Study ID Numbers ^ICMJE

CFEM345ADE03

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

NCIC CTG

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

April 2012

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

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