Status:
COMPLETED
Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin and Carboplatin in Malignant Gynecologic Tumours
Lead Sponsor:
AGO Study Group
Collaborating Sponsors:
MedServ. GmbH, Wiesbaden
Essex Pharma GmbH
Conditions:
Cancer of the Ovary Treated as 2nd Line Therapy
Muellerian Mixed Tumours
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 recu...
Detailed Description
Aim of these study is the evaluation of combination chemotherapy in a patient subset with gynecologic tumours on regard to tolerance and efficacy.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00189410
Start Date
June 1 2003
End Date
September 1 2006
Last Update
July 20 2010
Active Locations (19)
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1
Medical Practice Dr. Klare
Berlin, Germany, 10367
2
Evangelisches Krankenhaus, Dept. of Gynecology & Obstetrics
Düsseldorf, Germany, 40217
3
Univerisity Hospital; Dept. of Gynecology & Obstetrics
Erlangen, Germany, 91054
4
University hospital, Dept. of gynecology & obstetrics
Essen, Germany, 45122