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Published on: September 8, 2017
Weekly docetaxel for patients with platinum/paclitaxel/irinotecan-resistant relapsed ovarian cancer: a phase I study
Fumitoshi Terauchi1, Takayuki Hirano, Hideki Taoka
1Second Department of Obstetrics and Gynecology, Toho University School of Medicine, 2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan. teralfa@aol.com
Background:
This study was designed to investigate the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended dose (RD) of weekly docetaxel treatment in patients with relapsed ovarian cancer after the administration of platinum/paclitaxel/irinotecan.
Methods:
Patients were enrolled on the basis of inclusion and exclusion criteria. Docetaxel was administered intravenously over a 60-min period on days 1, 8, and 15. Four dosage levels, 30, 35, 40, and 45 mg/m2, were employed, and the dosage was escalated from level 1 to level 4. DLT criteria were established, and the DLT was used as the criterion for deciding the MTD and RD.
Results:
Twelve patients were enrolled. No grade 3/4 hematological toxicities were manifested at any dosage level. Grade 3/4 nonhematologic toxicities were manifested at level 4, consisting of fatigue/asthenia in 2 patients and neuropathy/sensory toxicity in 1 patient. Level 4 (45 mg/m2) was thus judged to be the MTD, and the RD was concluded to be one level lower, i.e., level 3 (40 mg/m2).
Conclusions:
It was concluded that the RD for weekly docetaxel therapy is 40 mg/m2 per week in patients with relapsed ovarian cancer after the administration of platinum/paclitaxel/irinotecan.
