Phase I study on pegylated liposomal doxorubicin in combination with docetaxel for patients with platinum-resistant or partially platinum-sensitive epithelial ovarian cancer: The Kansai Clinical Oncology Group study
Kensuke Hori1, Kimihiko Ito1, Kentaro Kuritani2, Shiho Kuji3, Naoto Furukawa4, Hiroshi Tsubamoto5, Atsushi Arakawa6
1 Department of Obstetrics and Gynecology, Kansai Rosai Hospital, Amagasaki, Japan
2 Department of Obstetrics and Gynecology, Osaka Rosai Hospital, Sakai, Japan
3 Department of Gynecology, Shizuoka Cancer Center, Nagaizumichou, Shizuoka, Japan
4 Department of Obstetrics and Gynecology, Nara Prefectural Seiwa Medical Center, Ikoma-Gun, Japan
5 Department of Obstetrics and Gynecology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan
6 Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Aichi, Japan
Department of Obstetrics and Gynecology, Kansai Rosai Hospital, Inabasou, Amagasaki, Hyogo
Source of Support: None, Conflict of Interest: None
Context: In platinum-resistant ovarian cancer, single-agent chemotherapy is recommended for the reduction of adverse events. However, in clinical practice, some patients can tolerate drug-specific adverse events.
Aims: We assessed the safety of pegylated liposomal doxorubicin (PEG-LD) and docetaxel regimen in the first cycle of ovarian cancer.
Settings and Design: We performed a phase I study to evaluate the combination therapy of PEG-LD and docetaxel.
Materials and Methods: We recruited five patients with recurrent ovarian cancer within 12 months of first-line platinum-based chemotherapy. All patients had measurable disease severity. PEG-LD and docetaxel were intravenously administered on day 1 and every 21 days using three dose levels: 25 mg/m2 PEG-LD and 50 mg/m2 docetaxel; 30 mg/m2 PEG-LD and 50 mg/m2 docetaxel; and 30 mg/m2 PEG-LD and 60 mg/m2 docetaxel.
Statistical Analysis Used: We defined the maximum tolerated dose of the combination therapy based on the modified Fibonacci method.
Results: Five patients were enrolled in this study. The median treatment-free interval was 5.5 months. Two dose-limiting toxicities (Grade 4 neutropenia) were observed in two patients. One complete response, one partial response, one stable disease, and two progressive disease cases were observed. The overall response rate was 2/5, and the disease control rate was 3/5. The median overall survival was 7.4 months.
Conclusions: We determined that 25 mg/m2 of PEG-LD and 50 mg/m2 of docetaxel were safe and effective doses. This preliminary efficacy and safety data should be further investigated in a Phase II trial.