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| Sponsor: | AGO Study Group |
|---|---|
| Collaborators: |
MedServ. GmbH, Wiesbaden Essex Pharma GmbH |
| Information provided by: | AGO Study Group |
| ClinicalTrials.gov Identifier: | NCT00189410 |
Purpose
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 |
|---|---|---|
|
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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
| Enrollment: | 140 |
| Study Start Date: | June 2003 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Aim of these study is the evaluation of combination chemotherapy in a patient subset with gynecologic tumours on regard to tolerance and efficacy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| 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 | |
| Principal Investigator: | Andreas du Bois, MD PhD | AGO-OVAR, AGO Ovarian Cancer Study Group |
More Information
| Responsible Party: | Gabriele Elser, MedServ. GmbH, Wiesbaden |
| ClinicalTrials.gov Identifier: | NCT00189410 History of Changes |
| Other Study ID Numbers: | AGO-GYN 3 |
| Study First Received: | September 12, 2005 |
| Last Updated: | July 19, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Uterine Cervical Neoplasms Genital Neoplasms, Female Adenoma, Pleomorphic Ovarian Neoplasms Uterine Neoplasms Mixed Tumor, Mullerian Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type |
Adenoma Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders Doxorubicin Carboplatin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |