Advanced or recurrent endometrial carcinoma
Conditions
Interventions
Product Name: Exemestan
Pharmaceutical Form: Tablet
INN or Proposed INN: Exemestan
Concentration type: equal
Concentration number: 25-mg
Sponsors
Nordic Society for Gynecologic Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective response rate;Secondary Objective: Progression free survival overall survival Toxicity;Primary end point(s): Response rate | — |
Countries
Denmark
Outcome results
None listed