NCT05410483: A Dose-finding Trial of Hyperthermic Intraperitoneal Docetaxel

Summary

This is a single-center study design, and 30 patients will be enrolled. Eligible patients will receive docetaxel at different dose levels according to the trial schedule.All the enrolled patients were treated with docetaxel during the first HIPEC treatment and cisplatin during the second HIPEC treatment at 43℃ for 1 hour.The dose of docetaxel for patients in the next group was determined according to the incidence of dose-limiting toxicity (DLT) of the previous docetaxel dose level. Finally, the maximum tolerated dose (MTD) of docetaxel for HIPEC was calculated according to the incidence of dose-limiting toxicity.

Timeline

Start: 2022-03-01
Primary completion: 2023-02-01
Completion: 2023-02-01

Publications

You ZY, Wu MF, Li H, Ye YF, Wang LJ, Lin ZQ, Li J. A phase I dose-finding trial of hyperthermic intraperitoneal docetaxel combined with cisplatin in patients with advanced-stage ovarian cancer. J Gynecol Oncol. 2024 Jan;35(1):e1. doi: 10.3802/jgo.2024.35.e1. Epub 2023 Jul 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	60 mg/m2	Other
Subject	Docetaxel	Small molecule	65 mg/m2	Other
Subject	Docetaxel	Small molecule	70 mg/m2	Other
Subject	Docetaxel	Small molecule	75 mg/m2	Other

Indications

No indication recorded.