Weekly docetaxel for patients with platinum/paclitaxel/irinotecan-resistant relapsed ovarian cancer: a phase I study.
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.
Terauchi
Fumitoshi
F
Second Department of Obstetrics and Gynecology, Toho University School of Medicine, 2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan. teralfa@aol.com
Hirano
Takayuki
T
Taoka
Hideki
H
Masaki
Kazuo
K
Yamamoto
Yasuhiro
Y
Ogura
Hisao
H
Kubo
Harumi
H
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001247:Asthenia / Q000139:chemically induced; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005221:Fatigue / Q000209:etiology; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D016896:Treatment Outcome
D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D017239:Paclitaxel; D002945:Cisplatin; D002166:Camptothecin