Clinical Trial: Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin and Carboplatin in Malignant Gynecologic Tumours
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Trial With Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin (PLD) and Carboplatin in Malignant Gynecologic Tumour's
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 Summary: Aim of these study is the evaluation of combination chemotherapy in a patient subset with gynecologic tumours on regard to tolerance and efficacy.
Sponsor: AGO Study Group
Current Primary Outcome:
- Tolerance
- Response Rate mainly in malignant uterine tumours
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to Progression mainly in malignant uterine tumours
- Overall Survival mainly in malignant uterine tumours
Original Secondary Outcome: Same as current
Information By: AGO Study Group
Dates:
Date Received: September 12, 2005
Date Started: June 2003
Date Completion:
Last Updated: July 19, 2010
Last Verified: July 2010
