Phase II Study Evaluating PegLiposomal Doxorubicin (PLD) and Carboplatin Combination Chemotherapy in Gynecological Sarcomas and Mixed Epithelial-Mesenchymal Tumors
This study in patients with mesenchymal or mixed epithelial mesenchymal tumors of the ovary
or uterus is designed as a prospective single-arm, open - label, multicenter phase II study
to evaluate the efficacy of PegLiposomal Doxorubicin and Carboplatin combination
40 patients will be recruited to receive PegLiposomal Doxorubicin (PLD) in a continuous i.
v. infusion of at least 60 minutes at a dose of 40 mg/m2 on Day 1, followed by a 30-minute
i. v. carboplatin infusion according to AUC 6 (formula devised by Calvert et al).
Patients will get outpatients treatment. At screening the patients' eligibility will be
assessed, their baseline and demographic characteristics obtained, and baseline values for
the effect variables collected. Patients with measurable lesions, non-measurable lesions or
histological documentation will be included into this trial. Measurable lesion and
non-measurable lesions will be documented by x-ray, ultrasound, computed tomography or MRI.
The patients' safety will be monitored during therapy until recovery of toxicities.
In patients with measurable lesions at baseline, the (post)-treatment values for effect
according to the RECIST criteria will be collected as shown in table 6. CR, PR and SD have
to be confirmed by a repeat measurement after an interval of at least four weeks.
Follow-up is scheduled every three months during the first two years after the end of
As from year 3 the follow-up takes place outside the study in the context of general
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Anticancer activity in terms of progression-free survival time (PFS)
every 3 months
Philipp Harter, MD
Klinikum Essen Mitte
Germany: Federal Institute for Drugs and Medical Devices