Exemestane in Advanced and Recurrent Endometrial Carcinoma

Endometrial Cancer Clinical Trial

Official title:

Phase 2 Study of Exemestane in Advanced and Recurrent Endometrial Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965080
• Other study ID #: NSGO-EC-0302
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2013
• Last updated: October 15, 2013
• Start date: March 2004
• Est. completion date: February 2009

Study information

• Verified date: October 2013
• Source: Nordic Society for Gynaecologic Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

A phase II study of Exemestane in Advanced or recurrent endometrial carcinoma

Hypothesis: Treatment With Exemestane can give a response rate of at least 30%

Description:

Patients With Advanced or recurrent endometrial cancer of endometrioid type were treated With Exemestane tablets 25 mg daily.

Patients were grouped according to estrogen receptor status.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Advanced or recurrent endometrial cancer not considered for treatment modalities apart from hormonal treatment

• Endometrioid histology

• Age above 18 years

• Post menopausal status

• Performance status 0-2

• Informed consent

Exclusion Criteria:

• Congestive heart disease grade III.IV

• History of thromboembolic signs

• Other primary hormonal therapy

• Patients With symptomatic brain metastasis

• Severe hepatic or renal impairment

• Pregnancy, lactation or child bearing potential without adequate contraception

Study Design

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• Exemestane
One tablet Exemestane 25 mg daily

Locations

Country	Name	City	State
Norway	The Norwegian Radium Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Society for Gynaecologic Oncology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Toxicity	Asses toxicity to the treatment using Common Toxicity Criteria for Adverse Effects	Up to 2 years	Yes
Primary	Response rate	Objective response rate within 6 months of treatment	6 months	No
Secondary	Progression free survival	Special attention to progression status at 6 months	2 years	No