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J Korean Cancer Assoc > Volume 32(5); 2000 > Article
Journal of the Korean Cancer Association 2000;32(5): 895-903.
Phase I Clinical Trial of Paclitaxel Plus Ifosfamide for the Patients with Refractory Ovarian Cancer
Ho Sawk Saw, Jae Kwan Lee
Department of Obstetrics and Gynecology, Korea University School of Medicine, Seoul, Korea. hssaw@kuccnx.korea.ac.kr
Patients with advanced ovarian carcinoma and refractory to platinum based chemotherapy have a very poor prognosis and effective salvage regimens are needed. This study was conducted in order to determine the maximum tolerated dose (MTD) and dose limiting toxicity of combination with paclitaxel and ifosfamide.
After premedication, patients received paclitaxel (110~225 mg/m2) as a 24 hour IV infusion on day 1. Ifosfamide (1,000~1,500 mg/m2) was given as a 12 hour IV infusion with standard dose of mesna on day 2~6. All patients received G-CSF (granulocyte colony stimulating factor) on day 6~15.
12 patients with advanced ovarian cancer entered this trial. Toxicity included bone marrow suppression, neuromuscular toxicity, urothelial toxicity, gastrointestinal toxicity, which occurred in 84.6%, 65.3%, 30.7%, 88.4% of cycles.
Neuromuscular toxicity was dose limiting toxicity. Maximum tolerated dose in com bination with paclitaxel and ifosfamide was 175 mg/m2 of paclitaxel and 1,500 mg/m2 of ifosfamide.
Key words: Ovary neoplasm;Chemotherapy;Phase I;Paclitaxel;Ifosfamide;Dose limiting toxicity;Maximum tolerated dose
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