A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University