Exemestane in Advanced or Recurrent Endometrial Carcinoma.A multicentre non-randomized Phase II study

• Conditions: Advanced or recurrent endometrial carcinoma

• Registration Number: EUCTR2004-001103-35-DK
• Lead Sponsor: ordic Society for Gynecologic Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

•Advanced endometrial cancer (stage III-IV), not considered for treatment modalities apart from hormonal treatment
•Relapse after primary treatment with interval > 1 month
•Measurable tumour by X-ray examination and/or CT and/or MRI outside irradiated area.
•Histological verified endometrial cancer. Only patients with tumors of endometrioid type will be accepted.
•Post-menopausal women
•Expected survival > 6 month
•Age must be at least 18 years
•Performance status must be 0-2 (WHO/ECOG, appendix I)
•Informed consent given according to ICH/EU GCP guidelines and local or national laws

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Congestive heart failure grade III-IV
•Severe hepatic or renal impairment not allowing for adequate use of the proposed regimens. ASAT or ALAT > 4 times of the upper limit of the normal values. S-Creatinine >150 mmol/l
•Other malignancies within the last 5 years apart from cancer in situ cervicis uteri or basal cell carcinoma of the skin.
•History of tromboembolic signs.
•Any treatment that interact with the study drug like carbamazepine or cyclosporine.
•Other primary hormonal therapy.
•Tumors consisting of or with elements of serous papillary (UPSC) or clear cell type.
•Inclusion in other trials.
•Any cancer treatment or use of any investigation agent within one month of the study entry.
•Circumstances at the time of the entry that would not permit completion of the study or follow-up.
•Patients with symptomatic brain metastases.
•Pregnancy, lactation or child bearing potential patients without adequate contraception
•Dementia or significantly altered status that would prohibit the understanding and giving of informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Objective response rate;Secondary Objective: Progression free survival<br>overall survival<br>Toxicity;Primary end point(s): Response rate