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

Phase II Trial With Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin (PLD) and Carboplatin in Malignant Gynecologic Tumour's

Pegylated Liposomal Doxorubicin as well as Carboplatin have been showed efficacy in monotherapy as in combination therapy of gynaecologic tumours. As there is no common standard in the therapy of recurrent ovarian carcinoma, tumours of the uterus nor for non-epithelial ovarian tumours at time of designing of this study, this trial shall evaluate the new and well tolerated combination therapy consisting of Pegylated Liposomal Doxorubicin and Carboplatin.

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