Exemestane in Advanced and Recurrent Endometrial Carcinoma
Information source: Nordic Society for Gynaecologic Oncology
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endometrial Cancer
Intervention: Exemestane (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Nordic Society for Gynaecologic Oncology Official(s) and/or principal investigator(s): Gunnar Kristensen, MD, PhD, Study Chair, Affiliation: NSGO
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%
Clinical Details
Official title: Phase 2 Study of Exemestane in Advanced and Recurrent Endometrial Carcinoma
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Response rate
Secondary outcome: Progression free survival
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
The Norwegian Radium Hospital, Oslo 0310, Norway
Additional Information
Starting date: March 2004
Last updated: October 15, 2013
|