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Completed

NCT Number: NCT01965080

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%

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

The Norwegian Radium Hospital

Oslo, 0310, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exemestane

Drug

One tablet Exemestane 25 mg daily

Other names: Aromasin

Primary outcomes

  1. Response rate

    Time frame: 6 months

    Objective response rate within 6 months of treatment

Secondary outcomes

  1. Progression free survival

    Time frame: 2 years

    Special attention to progression status at 6 months

Other outcomes

  1. Toxicity

    Time frame: Up to 2 years

    Asses toxicity to the treatment using Common Toxicity Criteria for Adverse Effects

Sponsors and collaborators

Lead sponsor

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Other

Registry information

Official study title

Phase 2 Study of Exemestane in Advanced and Recurrent Endometrial Carcinoma

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Oct 18, 2013
Registry last updated
Oct 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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