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Exemestane in Advanced and Recurrent Endometrial Carcinoma

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Exemestane
Sponsored by
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring Endometrial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Norwegian Radium Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exemestane

Arm Description

Exemestane 25 mg daily

Outcomes

Primary Outcome Measures

Response rate
Objective response rate within 6 months of treatment

Secondary Outcome Measures

Progression free survival
Special attention to progression status at 6 months

Full Information

First Posted
September 26, 2013
Last Updated
October 15, 2013
Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
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1. Study Identification

Unique Protocol Identification Number
NCT01965080
Brief Title
Exemestane in Advanced and Recurrent Endometrial Carcinoma
Official Title
Phase 2 Study of Exemestane in Advanced and Recurrent Endometrial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Endometrial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exemestane
Arm Type
Experimental
Arm Description
Exemestane 25 mg daily
Intervention Type
Drug
Intervention Name(s)
Exemestane
Other Intervention Name(s)
Aromasin
Intervention Description
One tablet Exemestane 25 mg daily
Primary Outcome Measure Information:
Title
Response rate
Description
Objective response rate within 6 months of treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Progression free survival
Description
Special attention to progression status at 6 months
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Toxicity
Description
Asses toxicity to the treatment using Common Toxicity Criteria for Adverse Effects
Time Frame
Up to 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Kristensen, MD, PhD
Organizational Affiliation
NSGO
Official's Role
Study Chair
Facility Information:
Facility Name
The Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
0310
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
24498853
Citation
Lindemann K, Malander S, Christensen RD, Mirza MR, Kristensen GB, Aavall-Lundqvist E, Vergote I, Rosenberg P, Boman K, Nordstrom B. Examestane in advanced or recurrent endometrial carcinoma: a prospective phase II study by the Nordic Society of Gynecologic Oncology (NSGO). BMC Cancer. 2014 Feb 5;14:68. doi: 10.1186/1471-2407-14-68.
Results Reference
derived

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Exemestane in Advanced and Recurrent Endometrial Carcinoma

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