Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin and Carboplatin in Malignant Gynecologic Tumours

Aim of these study is the evaluation of combination chemotherapy in a patient subset with gynecologic tumours on regard to tolerance and efficacy.

Inclusion criteria

• Histologically confirmed diagnosis of a gynecologic tumour [(non-epithelial ovarian tumour without germcell-tumours, tumours of the uterus (eg. Muellerian mixed tumours, Endometrial carcinomas, Uterus sarcoma, Cancer of the cervix)]
• Target or non-target lesion. Patients with epithelial ovarian carcinoma are qualified also if they have a CA 125 increase only.
• Patients with ovarian carcinoma must have completed a platin-containing chemotherapy more than 6 months at least. Patients with other malignancies could have prior chemotherapy, but must'nt
• Prior Radiotherapy less than 25% of haemapoietic system is allowed, but should have completed at least 6 weeks prior or registration
• Prior antitumoral hormone therapy, or specific immunotherapy is allowed, treatment have to be completed at least 3 weeks prior of registration
• All women with childbearing potential have to be a negative pregnancy test within 7 days of registration
• Perfomance Status 0-2 ECOG or more than 60% according to Karnofsky Index
• Estimated expectancy of life of more than 12 weeks
• adequate hematologic, renal and hepatic function according to following definitions: absolute Neutrophils >= 1,5 n/L Platelets >= 100 n/L Bilirubine <= 1,25 x ULN estimated glomerular filtration rate (Jelliffe) >= 60 ml/min
• Patients who have given their signed and written informed consent to participate in the trial
• Patients must be geographically accessible for treatment and follow

Exclusion criteria

• More than 2 prior chemotherapies (or Radio-Chemotherapies)
• active infection or concurrent severe medical problems unrelated to malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
• application of other cytotoxic or antitumoral agents during study period
• Patients with a history of seizure disorder or central nervous system disorders
• History of congestive heart failure (NYHA Classification > 2, even if medically controlled.
• History of clinical and electrocardiographically documented myocardial infarction within the last 6 months.
• History of atrial or ventricular arrhythmias (> LOWN II)
• Women who are pregnant or breast feeding
• Fertile women not using adequate contraceptive measures
• Patients who have used any investigational drugs within 30 days of study entry