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A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin in Patients With Advanced-stage Ovarian Cancer
Primary objective of this trial is to identify the maximum tolerated dose (MTD) of paclitaxel combined with a fixed dose of cisplatin (75 mg/m2) delivered as hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian cancer. In this single-center Phase I trial, Bayesian Optimal Interval Design (TITE-BOIN) was used. The starting dose for paclitaxel was 175 mg/m2, with escalation in 25 mg/m2 increments until the MTD was determined or the maximum dose level of 225 mg/m2 was reached. The target dose-limiting toxicity (DLT) rate was 25%, and the total sample size was 30 patients.
Age
18 - 75 years
Sex
FEMALE
Healthy Volunteers
No
Sun Yat-sen Memorial Hospital
Guangzhou, Other (Non U.s.), China
Start Date
December 1, 2022
Primary Completion Date
May 1, 2023
Completion Date
May 1, 2023
Last Updated
November 17, 2022
30
ESTIMATED participants
Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
DRUG
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
NCT05039801
NCT04550494
Data Source & Attribution
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