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