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drugset / Trial / NCT05620654

A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin

NCT05620654 ↗

Phase 1 Unknown 30 enrolled Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-12-01
Primary completion
2023-05-01
Completion
2023-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 175 mg/m2 Other
Subject Paclitaxel Small molecule 200 mg/m2 Other
Subject Paclitaxel Small molecule 225 mg/m2 Other
Background Cisplatin Other / unclassified 75 mg/m2 Other

Indications

ovarian cancer