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

Sponsor

AGO Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00189410

Collaborator

MedServ. GmbH, Wiesbaden (Other), Essex Pharma GmbH (Industry)

140

Enrollment

Locations

Duration (Months)

7.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of the Ovary Treated as 2nd Line Therapy Muellerian Mixed Tumours Tumours of the Uterus Cervical Cancers Non-Epithelial Ovarian Tumours	Drug: Pegylated Liposomal Doxorubicin and Carboplatin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Sep 1, 2005

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

Tolerance []
Response Rate mainly in malignant uterine tumours []

Secondary Outcome Measures

Time to Progression mainly in malignant uterine tumours []
Overall Survival mainly in malignant uterine tumours []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Medical Practice Dr. Klare	Berlin	Germany	10367
2	Evangelisches Krankenhaus, Dept. of Gynecology & Obstetrics	Duesseldorf	Germany	40217
3	Univerisity Hospital; Dept. of Gynecology & Obstetrics	Erlangen	Germany	91054
4	University hospital, Dept. of gynecology & obstetrics	Essen	Germany	45122
5	University hospital , Dept. gynecologic & obestretics	Frankfurt	Germany	60596
6	University of Freiburg; Dept of Gynecology & Obstetrics	Freiburg	Germany	79106
7	Ernst-Moritz-Arndt University, Dept. of Gynecology & Obstetrics	Greifswald	Germany	17487
8	MH Hannover, Dept. of Gynecology & Obstetrics	Hannover	Germany	30625
9	St. Vincentius Hospital, Dept. of Gynecology & Obstetrics	Karlsruhe	Germany	76137
10	Univerisity Clinic Schleswig-Holstein, Campus Kiel, Dept. for gynecology & obstetrics	Kiel	Germany	24105
11	Otto-von-Guericke Univerisity, Dept. of Gynecology & Obstetrics	Magdeburg	Germany	39108
12	University hospital, Dept. of Gynecology & Obstetrics	Mainz	Germany	55101
13	Phillips University, Clinic fo gynecology, gyn endocrinology and oncology	Marburg	Germany	35033
14	University hospital Muenchen-Grosshadern, Dept. of gynecology & obstetrics	Muenchen	Germany	81377
15	University Hospital TU Muenchen; Dept. of Gynecology & Obstetrics	Muenchen	Germany	81675
16	Humaine Vogtlandklinikum; Dept. of gynecology & obstetrics	Plauen	Germany	08529
17	University hospital, Dept. gynecology & obstetrics	Tuebingen	Germany	72076
18	Schwarzwald-Baar Klinikum Villingen, Dept. Gynecology	Villingen-Schwenningen	Germany	78050
19	HSK, Dr. Horst Schmidt Klinik, Dept. of Gynecology & Gyn. Oncology	Wiesbaden	Germany	D-65199