E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
primary advanced or recurrent/metastatic endometrial cancer |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 <1,25 upper limit of norm
o Bilirubin <1,25 upper limit of norm
o GOT/GPT <3 upper limit of norm
o Glomerular filtration rate >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 |
|
E.4 | Principal exclusion criteria | |
E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint:
• Response rate
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 17 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
23 response evaluable patients will be entered in the first stage. If 7 or more responses are observed from the first 23 patients accrued, recruitment will continue into stage 2 and another 16 patients will be entered. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |