Multicenter Trial With PegLiposomal Doxorubicin and Carboplatin Combination Chemotherapy in Gynecological Sarcomas and Mixed Epithelial-Mesenchymal Tumors

Inclusion 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 \< 1cm) may be enrolled only if cisplatin-ifosfamide combination therapy is not feasible.
* Patients with metastatic uterine carcinosarcoma may be enrolled only if Ifosfamide/Paclitaxel combination therapy is not feasible.
* Patients with metastatic leiomyosarcoma may be enrolled only if gemcitabine-docetaxel combination therapy is not feasible.
* Measurable (target lesion) tumor, evaluable (non-target lesion) tumor or histological documentation
* No more than one prior chemotherapy. Any prior platinum or anthracycline- containing chemotherapy must have been completed more than 6 months previously
* Prior radiotherapy ≤ 25% of the hematopoietic system is allowed provided it took place more than 6 weeks before recruitment
* Patients are allowed to have received prior anticancer hormone therapy or specific immunotherapy. Patients must have completed these therapies at least three weeks before recruitment to the study
* All women with a theoretical possibility of pregnancy must produce a negative pregnancy test (serum or urinary) within seven days before starting treatment
* General health of 0 - 2 on the ECOG score
* At least 18 years of age
* Estimated life expectancy above 12 weeks
* At least 3 weeks since major surgery
* Appropriate hematologic, renal and hepatic function in accordance with the following definitions:
* Absolute neutrophil count (ANC) ≥ 1.5 × 109 /l
* Platelets ≥ 100 × 10 9/l
* Total bilirubin ≤ 1.25 times upper limit of normal
* Estimated GFR ≥ 50 ml/min
* LVEF \> 50 %
* Informed consent must be obtained from all patients.

Exclusion 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