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

Primary Purpose

Cancer of the Ovary Treated as 2nd Line Therapy, Muellerian Mixed Tumours, Tumours of the Uterus

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Pegylated Liposomal Doxorubicin and Carboplatin
Sponsored by
AGO Study Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of the Ovary Treated as 2nd Line Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Medical Practice Dr. Klare
  • Evangelisches Krankenhaus, Dept. of Gynecology & Obstetrics
  • Univerisity Hospital; Dept. of Gynecology & Obstetrics
  • University hospital, Dept. of gynecology & obstetrics
  • University hospital , Dept. gynecologic & obestretics
  • University of Freiburg; Dept of Gynecology & Obstetrics
  • Ernst-Moritz-Arndt University, Dept. of Gynecology & Obstetrics
  • MH Hannover, Dept. of Gynecology & Obstetrics
  • St. Vincentius Hospital, Dept. of Gynecology & Obstetrics
  • Univerisity Clinic Schleswig-Holstein, Campus Kiel, Dept. for gynecology & obstetrics
  • Otto-von-Guericke Univerisity, Dept. of Gynecology & Obstetrics
  • University hospital, Dept. of Gynecology & Obstetrics
  • Phillips University, Clinic fo gynecology, gyn endocrinology and oncology
  • University hospital Muenchen-Grosshadern, Dept. of gynecology & obstetrics
  • University Hospital TU Muenchen; Dept. of Gynecology & Obstetrics
  • Humaine Vogtlandklinikum; Dept. of gynecology & obstetrics
  • University hospital, Dept. gynecology & obstetrics
  • Schwarzwald-Baar Klinikum Villingen, Dept. Gynecology
  • HSK, Dr. Horst Schmidt Klinik, Dept. of Gynecology & Gyn. Oncology

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
July 19, 2010
Sponsor
AGO Study Group
Collaborators
MedServ. GmbH, Wiesbaden, Essex Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00189410
Brief Title
Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin and Carboplatin in Malignant Gynecologic Tumours
Official Title
Phase II Trial With Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin (PLD) and Carboplatin in Malignant Gynecologic Tumour's
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AGO Study Group
Collaborators
MedServ. GmbH, Wiesbaden, Essex Pharma GmbH

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Ovary Treated as 2nd Line Therapy, Muellerian Mixed Tumours, Tumours of the Uterus, Cervical Cancers, Non-Epithelial Ovarian Tumours

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pegylated Liposomal Doxorubicin and Carboplatin
Primary Outcome Measure Information:
Title
Tolerance
Title
Response Rate mainly in malignant uterine tumours
Secondary Outcome Measure Information:
Title
Time to Progression mainly in malignant uterine tumours
Title
Overall Survival mainly in malignant uterine tumours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas du Bois, MD PhD
Organizational Affiliation
AGO-OVAR, AGO Ovarian Cancer Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Practice Dr. Klare
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
Evangelisches Krankenhaus, Dept. of Gynecology & Obstetrics
City
Duesseldorf
ZIP/Postal Code
40217
Country
Germany
Facility Name
Univerisity Hospital; Dept. of Gynecology & Obstetrics
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
University hospital, Dept. of gynecology & obstetrics
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
University hospital , Dept. gynecologic & obestretics
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
University of Freiburg; Dept of Gynecology & Obstetrics
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Ernst-Moritz-Arndt University, Dept. of Gynecology & Obstetrics
City
Greifswald
ZIP/Postal Code
17487
Country
Germany
Facility Name
MH Hannover, Dept. of Gynecology & Obstetrics
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
St. Vincentius Hospital, Dept. of Gynecology & Obstetrics
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Facility Name
Univerisity Clinic Schleswig-Holstein, Campus Kiel, Dept. for gynecology & obstetrics
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Otto-von-Guericke Univerisity, Dept. of Gynecology & Obstetrics
City
Magdeburg
ZIP/Postal Code
39108
Country
Germany
Facility Name
University hospital, Dept. of Gynecology & Obstetrics
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Phillips University, Clinic fo gynecology, gyn endocrinology and oncology
City
Marburg
ZIP/Postal Code
35033
Country
Germany
Facility Name
University hospital Muenchen-Grosshadern, Dept. of gynecology & obstetrics
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
University Hospital TU Muenchen; Dept. of Gynecology & Obstetrics
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Humaine Vogtlandklinikum; Dept. of gynecology & obstetrics
City
Plauen
ZIP/Postal Code
08529
Country
Germany
Facility Name
University hospital, Dept. gynecology & obstetrics
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Schwarzwald-Baar Klinikum Villingen, Dept. Gynecology
City
Villingen-Schwenningen
ZIP/Postal Code
78050
Country
Germany
Facility Name
HSK, Dr. Horst Schmidt Klinik, Dept. of Gynecology & Gyn. Oncology
City
Wiesbaden
ZIP/Postal Code
D-65199
Country
Germany

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
background
Links:
URL
http://www.ago-ovar.de
Description
Homepage of the AGO Ovarian Cancer Study Group

Learn more about this trial

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

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