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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00189410
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : July 20, 2010
MedServ. GmbH, Wiesbaden
Essex Pharma GmbH
Information provided by:
AGO Study Group

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 Type : Interventional  (Clinical Trial)
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 : June 2003
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2006

Primary Outcome Measures :
  1. Tolerance
  2. Response Rate mainly in malignant uterine tumours

Secondary Outcome Measures :
  1. Time to Progression mainly in malignant uterine tumours
  2. Overall Survival mainly in malignant uterine tumours

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00189410

Medical Practice Dr. Klare
Berlin, Germany, 10367
Evangelisches Krankenhaus, Dept. of Gynecology & Obstetrics
Duesseldorf, Germany, 40217
Univerisity Hospital; Dept. of Gynecology & Obstetrics
Erlangen, Germany, 91054
University hospital, Dept. of gynecology & obstetrics
Essen, Germany, 45122
University hospital , Dept. gynecologic & obestretics
Frankfurt, Germany, 60596
University of Freiburg; Dept of Gynecology & Obstetrics
Freiburg, Germany, 79106
Ernst-Moritz-Arndt University, Dept. of Gynecology & Obstetrics
Greifswald, Germany, 17487
MH Hannover, Dept. of Gynecology & Obstetrics
Hannover, Germany, 30625
St. Vincentius Hospital, Dept. of Gynecology & Obstetrics
Karlsruhe, Germany, 76137
Univerisity Clinic Schleswig-Holstein, Campus Kiel, Dept. for gynecology & obstetrics
Kiel, Germany, 24105
Otto-von-Guericke Univerisity, Dept. of Gynecology & Obstetrics
Magdeburg, Germany, 39108
University hospital, Dept. of Gynecology & Obstetrics
Mainz, Germany, 55101
Phillips University, Clinic fo gynecology, gyn endocrinology and oncology
Marburg, Germany, 35033
University hospital Muenchen-Grosshadern, Dept. of gynecology & obstetrics
Muenchen, Germany, 81377
University Hospital TU Muenchen; Dept. of Gynecology & Obstetrics
Muenchen, Germany, 81675
Humaine Vogtlandklinikum; Dept. of gynecology & obstetrics
Plauen, Germany, 08529
University hospital, Dept. gynecology & obstetrics
Tuebingen, Germany, 72076
Schwarzwald-Baar Klinikum Villingen, Dept. Gynecology
Villingen-Schwenningen, Germany, 78050
HSK, Dr. Horst Schmidt Klinik, Dept. of Gynecology & Gyn. Oncology
Wiesbaden, Germany, D-65199
Sponsors and Collaborators
AGO Study Group
MedServ. GmbH, Wiesbaden
Essex Pharma GmbH
Principal Investigator: Andreas du Bois, MD PhD AGO-OVAR, AGO Ovarian Cancer Study Group

Additional Information:
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

Responsible Party: Gabriele Elser, MedServ. GmbH, Wiesbaden Identifier: NCT00189410     History of Changes
Other Study ID Numbers: AGO-GYN 3
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: July 20, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Ovarian Neoplasms
Genital Neoplasms, Female
Uterine Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Endocrine Gland Neoplasms
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action