J Korean Cancer Assoc.  2000 Oct;32(5):895-903.

Phase I Clinical Trial of Paclitaxel Plus Ifosfamide for the Patients with Refractory Ovarian Cancer

• Saw HS
• Lee JK

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.

Keyword

Ovary neoplasm; Chemotherapy; Phase I; Paclitaxel; Ifosfamide; Dose limiting toxicity; Maximum tolerated dose

MeSH Terms

Bone Marrow
Drug Therapy
Granulocyte Colony-Stimulating Factor
Humans
Ifosfamide*
Maximum Tolerated Dose
Mesna
Ovarian Neoplasms*
Paclitaxel*
Platinum
Premedication
Prognosis
Granulocyte Colony-Stimulating Factor
Ifosfamide
Mesna
Paclitaxel
Platinum