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The Safety of Pegylated Liposomal Doxorubicin Plus Irinotecan in Recurrent Ovarian Cancer Patients: A Phase I Trial.

AIM
The study was designed to evaluate the safety of combined chemotherapy with pegylated liposomal doxorubicin (PLD) and irinotecan (CPT-11) in patients with recurrent ovarian cancer.


PATIENTS AND METHODS
Six patients with platinum-resistant and taxane-pretreated ovarian cancer were enrolled in the study based on the traditional 3-plus-3 design. PLD was administered intravenously on day 1 and CPT-11 on days 1 and 8 of each 28-day course. Initial doses were 30 mg/m(2) PLD and 50 mg/m(2) CPT-11.


RESULTS
Hematotoxicity was the principal toxicity (1 patient developed grade 3 neutropenia and 2 developed grade 3 leukocytopenia); hand-foot syndrome was not observed. Furthermore, 1 patient achieved complete response, whereas 2 patients achieved partial response.


CONCLUSION
The combined PLD and CPT-11 regimen was well-tolerated indicating its potential clinical benefit for ovarian cancer patients.