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

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ClinicalTrials.gov Identifier: NCT00189410
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : July 20, 2010
Sponsor:
Collaborators:
MedServ. GmbH, Wiesbaden
Essex Pharma GmbH
Information provided by:
AGO Study Group

September 12, 2005
September 19, 2005
July 20, 2010
June 2003
September 2005   (Final data collection date for primary outcome measure)
  • Tolerance
  • Response Rate mainly in malignant uterine tumours
Same as current
Complete list of historical versions of study NCT00189410 on ClinicalTrials.gov Archive Site
  • Time to Progression mainly in malignant uterine tumours
  • Overall Survival mainly in malignant uterine tumours
Same as current
Not Provided
Not Provided
 
Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin and Carboplatin in Malignant Gynecologic Tumours
Phase II Trial With Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin (PLD) and Carboplatin in Malignant Gynecologic Tumour's
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.
Aim of these study is the evaluation of combination chemotherapy in a patient subset with gynecologic tumours on regard to tolerance and efficacy.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
Not Provided
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
Same as current
September 2006
September 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00189410
AGO-GYN 3
Not Provided
Not Provided
Not Provided
Gabriele Elser, MedServ. GmbH, Wiesbaden
AGO Study Group
  • MedServ. GmbH, Wiesbaden
  • Essex Pharma GmbH
Principal Investigator: Andreas du Bois, MD PhD AGO-OVAR, AGO Ovarian Cancer Study Group
AGO Study Group
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP