Phase I Clinical Trial of Paclitaxel Plus Ifosfamide for the Patients with Refractory Ovarian Cancer.
- Author:
Ho Sawk SAW
1
;
Jae Kwan LEE
Author Information
1. Department of Obstetrics and Gynecology, Korea University School of Medicine, Seoul, Korea. hssaw@kuccnx.korea.ac.kr
- Publication Type:Clinical Trial ; Original Article
- Keywords:
Ovary neoplasm;
Chemotherapy;
Phase I;
Paclitaxel;
Ifosfamide;
Dose limiting toxicity;
Maximum tolerated dose
- MeSH:
Bone Marrow;
Drug Therapy;
Granulocyte Colony-Stimulating Factor;
Humans;
Ifosfamide*;
Maximum Tolerated Dose;
Mesna;
Ovarian Neoplasms*;
Paclitaxel*;
Platinum;
Premedication;
Prognosis
- From:Journal of the Korean Cancer Association
2000;32(5):895-903
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
