A Multicenter Randomized Phase II Study of Docetaxel/Carboplatin Versus Docetaxel/Pegylated Liposomal Doxorubicin as Second Line Treatment in Patients With Platinum Sensitive Disease
The second-line treatment in advanced ovarian cancer has been proved effective in prolonging
overall survival and improving quality of life. In patients with platinum-sensitive ovarian
cancer (relapsed disease after 6 months from the end of first line chemotherapy) the
combination of paclitaxel/carboplatin is considered the standard treatment. Generally, the
combination platinum-based chemotherapy may well be associated with a survival benefit in
patients with platinum-sensitive disease. Carboplatin, pegylated doxorubicin (caelyx)
docetaxel, have been approved for second-line treatment of ovarian carcinoma and seem to be
active in platinum-sensitive disease.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
No
Christos Emmanouilides, MD
Principal Investigator
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
Greece: National Organization of Medicines
CT/05.09
NCT00758732
October 2005
March 2011
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