Brief Title
Exemestane in Advanced and Recurrent Endometrial Carcinoma
Official Title
Phase 2 Study of Exemestane in Advanced and Recurrent Endometrial Carcinoma
Brief 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%
Detailed 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response rate
Secondary Outcome
Progression free survival
Condition
Endometrial Cancer
Intervention
Exemestane
Study Arms / Comparison Groups
Exemestane
Description: Exemestane 25 mg daily
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
52
Start Date
March 2004
Completion Date
February 2009
Primary Completion Date
February 2009
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gunnar Kristensen, MD, PhD, ,
Location Countries
Norway
Location Countries
Norway
Administrative Informations
NCT ID
NCT01965080
Organization ID
NSGO-EC-0302
Responsible Party
Sponsor
Study Sponsor
Nordic Society for Gynaecologic Oncology
Study Sponsor
Gunnar Kristensen, MD, PhD, Study Chair, NSGO
Verification Date
October 2013