primary advanced or recurrent/metastatic endometrial cancer
Conditions
Sponsors
Studienzentrale AGO Austria
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Primary advanced (stage III or stage IV, according FIGO staging) or recurrent endometrial carcinoma, except Mixed Mullerian Carcinoma, serous carcinoma and clear cell carcinoma and carcinoma that is not curable by surgery. - Radiographically documented measurable disease. At least one site of disease must be unidimensionally measurable as follows: X-ray, physical exam > 20 mm } Spiral CT scan > 10 mm } Non-spiral CT scan > 20 mm } All radiology studies must be performed within 28 days prior to registration - Patient may not have received prior chemotherapy for recurrence - At least 12 months since last chemotherapy for adjuvant therapy containing anthracyclins (cumulative doses of anthracyclins: Epirubicin 600mg/m2; Doxorubicin 300mg/m2, Mitoxantrone 80mg/m2) - At least 4 weeks since completion of last radiotherapy involving the whole pelvis. - No radiotherapy planned during or after study chemotherapy prior of demonstrated progression - No endocrine or other anti-cancer-therapy during study chemotherapy - Adequate function of the bone marrow: o Platelets >100 000x109/l o Neutrophiles (ANC) >1,5x109/l o Hemoglobin >8,0 g/dl - Adequate organ functions: o Creatinine 40ml - Echocardiography within 4 weeks of study start showing left ventricular ejection fraction to be 50% or greater. - No history of myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure or symptoms suspicious for congestive heart failure unless the left ventricular ejection fraction is documented to be 50% or greater. - No third degree or complete heart block unless a pacemaker is in place. Patients on medications which alter cardiac conduction, such as digitalis, beta-blockers, or calcium channel blockers, or who have other conduction abnormalities or cardiac dysfunction may be placed on study at the discretion of the investigator. - ECOG performance status >2 (Appendix D). - Life expectancy >12 weeks. - Age >18 years. - No no prior chemotherapy for malignancy other than adjuvant treatment of endometrial cancer. - No concomitant medical illness like serious uncontrolled infection, uncontrolled angina or any other relevant illness, which, in the opinion of the treating physician makes the treatments prescribed on this study unfeasible for the patient. - No known sensitivities to study drugs. - Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. - Given written Informed Consent according to ICH/GCP rules 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:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: to assess, that the safety, feasibility, progression free survival and overall survival for the combination of liposomal-encapsulated doxorubicin citrate and carboplatin for primary advanced or recurrent/metastatic endometrial cancer is sufficiently active to the treatment with doxorubicin and cisplatin with acceptable toxicity;Primary end point(s): Primary endpoint: • Response rate ;Main Objective: to assess, that the response rate for the combination of liposomal-encapsulated doxorubicin citrate and carboplatin for primary advanced or recurrent/metastatic endometrial cancer is sufficiently active to the treatment with doxorubicin and cisplatin with acceptable toxicity | — |
Countries
Austria
Outcome results
None listed