Clinical trial NCT00189410: Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin and Carboplatin in Malignant Gynecologic Tumours
Official title: Phase II Trial With Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin (PLD) and Carboplatin in Malignant Gynecologic Tumour's
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer of the Ovary Treated as 2nd Line Therapy
Muellerian Mixed Tumours
Tumours of the Uterus
Cervical Cancers
Non-Epithelial Ovarian Tumours
Lead sponsor: AGO Study Group
Sponsor class: OTHER
Collaborators: name: MedServ. GmbH, Wiesbaden
name: Essex Pharma GmbH
First posted: 2005-09-19
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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

Primary outcomes:
measure: Tolerance
measure: Response Rate mainly in malignant uterine tumours
Secondary outcomes:
measure: Time to Progression mainly in malignant uterine tumours
measure: Overall Survival mainly in malignant uterine tumours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Medical Practice Dr. Klare
city: Duesseldorf
country: Germany
facility: Evangelisches Krankenhaus, Dept. of Gynecology & Obstetrics
city: Erlangen
country: Germany
facility: Univerisity Hospital; Dept. of Gynecology & Obstetrics
city: Essen
country: Germany
facility: University hospital, Dept. of gynecology & obstetrics
city: Frankfurt
country: Germany
facility: University hospital , Dept. gynecologic & obestretics
city: Freiburg
country: Germany
facility: University of Freiburg; Dept of Gynecology & Obstetrics
city: Greifswald
country: Germany
facility: Ernst-Moritz-Arndt University, Dept. of Gynecology & Obstetrics
city: Hannover
country: Germany
facility: MH Hannover, Dept. of Gynecology & Obstetrics
city: Karlsruhe
country: Germany
facility: St. Vincentius Hospital, Dept. of Gynecology & Obstetrics
city: Kiel
country: Germany
facility: Univerisity Clinic Schleswig-Holstein, Campus Kiel, Dept. for gynecology & obstetrics
city: Magdeburg
country: Germany
facility: Otto-von-Guericke Univerisity, Dept. of Gynecology & Obstetrics
city: Mainz
country: Germany
facility: University hospital, Dept. of Gynecology & Obstetrics
city: Marburg
country: Germany
facility: Phillips University, Clinic fo gynecology, gyn endocrinology and oncology
city: Muenchen
country: Germany
facility: University hospital Muenchen-Grosshadern, Dept. of gynecology & obstetrics
city: Muenchen
country: Germany
facility: University Hospital TU Muenchen; Dept. of Gynecology & Obstetrics
city: Plauen
country: Germany
facility: Humaine Vogtlandklinikum; Dept. of gynecology & obstetrics
city: Tuebingen
country: Germany
facility: University hospital, Dept. gynecology & obstetrics
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum Villingen, Dept. Gynecology
city: Wiesbaden
country: Germany
facility: HSK, Dr. Horst Schmidt Klinik, Dept. of Gynecology & Gyn. Oncology
Study officials:
affiliation: AGO-OVAR, AGO Ovarian Cancer Study Group
name: Andreas du Bois, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gropp M, du Bois A, Burges A, Meier W. Combination of Pegliposomal Doxorubicin (PLD) and Carboplatin in gynecologic tumors - An AGO Study Group Phase I/II trial. Int J Gycecol Cancer 2003:13 Suppl 1, p 112