Exemestane in Advanced and Recurrent Endometrial Carcinoma

October 15, 2013 updated by: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Phase 2 Study of Exemestane in Advanced and Recurrent Endometrial Carcinoma

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%

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0310
        • The Norwegian Radium Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exemestane
Exemestane 25 mg daily
Drug: Exemestane
One tablet Exemestane 25 mg daily
Other Names:
  • Aromasin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 6 months
Objective response rate within 6 months of treatment
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 2 years
Special attention to progression status at 6 months
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity
Time Frame: Up to 2 years
Asses toxicity to the treatment using Common Toxicity Criteria for Adverse Effects
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Investigators

  • Study Chair: Gunnar Kristensen, MD, PhD, NSGO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 26, 2013

First Submitted That Met QC Criteria

October 15, 2013

First Posted (Estimate)

October 18, 2013

Study Record Updates

Last Update Posted (Estimate)

October 18, 2013

Last Update Submitted That Met QC Criteria

October 15, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSGO-EC-0302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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