Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin and Carboplatin in Malignant Gynecologic Tumours
NCT ID: NCT00189410
Last Updated: 2010-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
140 participants
INTERVENTIONAL
2003-06-30
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Pegylated Liposomal Doxorubicin and Carboplatin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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MedServ. GmbH, Wiesbaden
UNKNOWN
Essex Pharma GmbH
INDUSTRY
AGO Study Group
OTHER
Responsible Party
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MedServ. GmbH, Wiesbaden
Principal Investigators
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Andreas du Bois, MD PhD
Role: PRINCIPAL_INVESTIGATOR
AGO-OVAR, AGO Ovarian Cancer Study Group
Locations
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Medical Practice Dr. Klare
Berlin, , Germany
Evangelisches Krankenhaus, Dept. of Gynecology & Obstetrics
Düsseldorf, , Germany
Univerisity Hospital; Dept. of Gynecology & Obstetrics
Erlangen, , Germany
University hospital, Dept. of gynecology & obstetrics
Essen, , Germany
University hospital , Dept. gynecologic & obestretics
Frankfurt, , Germany
University of Freiburg; Dept of Gynecology & Obstetrics
Freiburg im Breisgau, , Germany
Ernst-Moritz-Arndt University, Dept. of Gynecology & Obstetrics
Greifswald, , Germany
MH Hannover, Dept. of Gynecology & Obstetrics
Hanover, , Germany
St. Vincentius Hospital, Dept. of Gynecology & Obstetrics
Karlsruhe, , Germany
Univerisity Clinic Schleswig-Holstein, Campus Kiel, Dept. for gynecology & obstetrics
Kiel, , Germany
Otto-von-Guericke Univerisity, Dept. of Gynecology & Obstetrics
Magdeburg, , Germany
University hospital, Dept. of Gynecology & Obstetrics
Mainz, , Germany
Phillips University, Clinic fo gynecology, gyn endocrinology and oncology
Marburg, , Germany
University hospital Muenchen-Grosshadern, Dept. of gynecology & obstetrics
München, , Germany
University Hospital TU Muenchen; Dept. of Gynecology & Obstetrics
München, , Germany
Humaine Vogtlandklinikum; Dept. of gynecology & obstetrics
Plauen, , Germany
University hospital, Dept. gynecology & obstetrics
Tübingen, , Germany
Schwarzwald-Baar Klinikum Villingen, Dept. Gynecology
Villingen-Schwenningen, , Germany
HSK, Dr. Horst Schmidt Klinik, Dept. of Gynecology & Gyn. Oncology
Wiesbaden, , Germany
Countries
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References
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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
Related Links
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Homepage of the AGO Ovarian Cancer Study Group
Other Identifiers
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AGO-GYN 3
Identifier Type: -
Identifier Source: org_study_id
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