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- Title
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.
- Authors
Hori, Kensuke; Ito, Kimihiko; Kuritani, Kentaro; Kuji, Shiho; Furukawa, Naoto; Tsubamoto, Hiroshi; Arakawa, Atsushi
- Abstract
<bold>Context: </bold>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.<bold>Aims: </bold>We assessed the safety of pegylated liposomal doxorubicin (PEG-LD) and docetaxel regimen in the first cycle of ovarian cancer.<bold>Settings and Design: </bold>We performed a phase I study to evaluate the combination therapy of PEG-LD and docetaxel.<bold>Materials and Methods: </bold>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.<bold>Statistical Analysis Used: </bold>We defined the maximum tolerated dose of the combination therapy based on the modified Fibonacci method.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
DOXORUBICIN; OVARIAN epithelial cancer; DOCETAXEL; MENSTRUAL cycle; OVARIAN cancer; ONCOLOGY
- Publication
Journal of Cancer Research & Therapeutics, 2019, Vol 15, Issue 6, p1201
- ISSN
0973-1482
- Publication type
journal article
- DOI
10.4103/jcrt.JCRT_742_16