A Study of Letrozole in the Treatment of Endometrial Cancer

Recurrent and Metastatic Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333086
• Other study ID #: CFEM345ADE03
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2006
• Last updated: April 18, 2012
• Start date: January 2000

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Recurrent and Metastatic Endometrial Cancer

Intervention

Drug:
• Letrozole

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Canadian Cancer Trials Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of clinical response, time to progression of the disease, correlation of tumor response with pretreatment ER/PR status, histological grade and aromatase levels