Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AGO Study Group
With
MedServ. GmbH, Wiesbaden
Essex Pharma GmbH
Aim of these study is the evaluation of combination chemotherapy in a patient subset with gynecologic tumours on regard to tolerance and efficacy.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin and Carboplatin in Malignant Gynecologic Tumours
