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Sponsors and Collaborators: |
AGO Ovarian Cancer Study Group MedServ. GmbH, Wiesbaden Essex Pharma GmbH |
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Information provided by: | AGO Ovarian Cancer Study Group |
ClinicalTrials.gov Identifier: | NCT00189410 |
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 | Intervention | Phase |
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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 II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial With Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin (PLD) and Carboplatin in Malignant Gynecologic Tumour's |
Enrollment: | 140 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | September 2006 |
Aim of these study is the evaluation of combination chemotherapy in a patient subset with gynecologic tumours on regard to tolerance and efficacy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
HSK, Dr. Horst Schmidt Klinik, Dept. of Gynecology & Gyn. Oncology | |
Wiesbaden, Germany, D-65199 | |
Univerisity Clinic Schleswig-Holstein, Campus Kiel, Dept. for gynecology & obstetrics | |
Kiel, Germany, 24105 | |
University hospital , Dept. gynecologic & obestretics | |
Frankfurt, Germany, 60596 | |
University hospital, Dept. gynecology & obstetrics | |
Tuebingen, Germany, 72076 | |
University hospital, Dept. of gynecology & obstetrics | |
Essen, Germany, 45122 | |
University hospital Muenchen-Grosshadern, Dept. of gynecology & obstetrics | |
Muenchen, Germany, 81377 | |
Humaine Vogtlandklinikum; Dept. of gynecology & obstetrics | |
Plauen, Germany, 08529 | |
Medical Practice Dr. Klare | |
Berlin, Germany, 10367 | |
Schwarzwald-Baar Klinikum Villingen, Dept. Gynecology | |
Villingen-Schwenningen, Germany, 78050 | |
Evangelisches Krankenhaus, Dept. of Gynecology & Obstetrics | |
Duesseldorf, Germany, 40217 | |
University hospital, Dept. of Gynecology & Obstetrics | |
Mainz, Germany, 55101 | |
St. Vincentius Hospital, Dept. of Gynecology & Obstetrics | |
Karlsruhe, Germany, 76137 | |
Phillips University, Clinic fo gynecology, gyn endocrinology and oncology | |
Marburg, Germany, 35033 | |
Otto-von-Guericke Univerisity, Dept. of Gynecology & Obstetrics | |
Magdeburg, Germany, 39108 | |
Ernst-Moritz-Arndt University, Dept. of Gynecology & Obstetrics | |
Greifswald, Germany, 17487 | |
MH Hannover, Dept. of Gynecology & Obstetrics | |
Hannover, Germany, 30625 | |
Univerisity Hospital; Dept. of Gynecology & Obstetrics | |
Erlangen, Germany, 91054 | |
University Hospital TU Muenchen; Dept. of Gynecology & Obstetrics | |
Muenchen, Germany, 81675 | |
University of Freiburg; Dept of Gynecology & Obstetrics | |
Freiburg, Germany, 79106 |
Principal Investigator: | Andreas du Bois, MD PhD | AGO-OVAR, AGO Ovarian Cancer Study Group |
Study ID Numbers: | AGO-GYN 3 |
Study First Received: | September 12, 2005 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00189410 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Malignant Mixed Mullerian Tumor Uterine Diseases Endocrine System Diseases Urogenital Neoplasms Carboplatin Ovarian Diseases Doxorubicin |
Mixed Tumor, Mullerian Genital Diseases, Female Anti-Bacterial Agents Ovarian Cancer Uterine Neoplasms Endocrinopathy Adenoma, Pleomorphic Adenoma Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Gonadal Disorders Antineoplastic Agents Urogenital Neoplasms Ovarian Diseases Antibiotics, Antineoplastic Mixed Tumor, Mullerian Genital Diseases, Female Neoplasms by Site Therapeutic Uses Uterine Neoplasms Endocrine Gland Neoplasms Neoplasms by Histologic Type Ovarian Neoplasms |
Genital Neoplasms, Female Endocrine System Diseases Uterine Diseases Carboplatin Doxorubicin Pharmacologic Actions Adnexal Diseases Neoplasms Adenoma, Pleomorphic Adenoma Neoplasms, Complex and Mixed Neoplasms, Glandular and Epithelial |