Exemestane in Advanced and Recurrent Endometrial Carcinoma

Phase 2CompletedNCT01965080

Nordic Society of Gynaecological Oncology - Clinical Trials Unit52 enrolled

Overview

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%

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endometrial Cancer

Interventions

ExemestaneDRUG

One tablet Exemestane 25 mg daily

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

The Norwegian Radium Hospital

Oslo, Norway

Outcomes

Primary Outcomes

Response rate

Objective response rate within 6 months of treatment

Time frame: 6 months

Secondary Outcomes

Progression free survival

Special attention to progression status at 6 months

Time frame: 2 years

Data from ClinicalTrials.gov

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