Gynecologic Sarcomas and Mixed Epithelial-Mesenchymal Tumors
Conditions
Interventions
Trade Name: CAELYX 2mg/ml / Vial 10ml
Product Name: Caelyx
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Doxorubicin hydrochloride in pegylated liposomal formulation
Sponsors
GYN Research GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients treated according to this protocol must meet all of the following criteria: - Histologically documented mesenchymal or mixed epithelial-mesenchymal tumor of the ovary or uterus. - Patients with a primary diagnosis of FIGO I-IV uterine carcinosarcoma and optimum debulking (postoperative residual tumor = 1.5 * 10^9 /l - Platelets >= 100 * 10^9/l - Total bilirubin = 50 ml/min - LVEF >= 50 % - Informed consent must be obtained from all patients. 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: Patients treated according to this protocol must not meet any of the following criteria: - More than one prior chemotherapy (or radiochemotherapy) - Active infection or other serious medical impairment liable to affect the patient's ability to receive treatment according to protocol. - Administration of other chemotherapy drugs or other anticancer hormone treatments during the study. - History of clinically manifest atrial or ventricular arrhythmia (> LOWN II) and congestive heart failure, even if controlled by drugs (NYHA class > II). Documented myocardial infarction within 6 months before study enrollment. - Pregnant or breastfeeding women, or women not practicing appropriate birth control methods. - Participation in another study using experimental drugs within the last 30 days - Any other conditions or therapies which the physician believes might put the patient at risk or impair the study objective. - known hypersensitivity to carboplatin or pegylated liposomal doxorubicin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Anticancer activity in terms of progression-free survival time (PFS) The primary endpoint is progression free survival time (PFS) defined as the interval of time from date of enrollment to date of first documentation of progression pursuant to RECIST criteria.;Secondary Objective: • Tolerability, i.e. type, frequency, severity and duration of adverse reactions (CTCAE, Version 3.0) • Anticancer activity in patients with measurable or evaluable disease in terms of response rates (CR, PR, SD, PD) according to RECIST criteria • Overall survival: defined as the time from enrollment date to death date • Correlation of tumor marker CA-125 with imaging methods ;Primary end point(s): The primary efficacy endpoint will evaluate anticancer activity in terms of progression-free survival time after 6 cycles of chemotherapy. | — |
Countries
Germany
Outcome results
None listed