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

Ovarian Cancer Clinical Trial

Official title:

A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin in Patients With Advanced-stage Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05620654
• Other study ID #: 2021-KY-132
• Status: Recruiting
• Phase: Phase 1
• Start date: December 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: November 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Jing Li, MD
• Phone: 008602034071260
• Email: lijing228[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age between 18 and 65 years;

• adequate renal function (blood creatinine: 58-96 µmol/L), bone marrow function (hemoglobin = 110 g/L, white cell count = 4.0 ×109/L, neutrophil count = 2.0 × 109/L, platelet count = 100 × 109/L) and hepatic function [bilirubin 3.4-22.2 µmol/L, alanine aminotransferase (ALT) 7-40 U/L, aspartate aminotransferase (AST) 13-35 U/L, AST/ALT= 1.5].

Exclusion Criteria:

• Patients who had been treated with cisplatin OR paclitaxel for any reason within 3 weeks prior to HIPEC.

• A history of HIPEC treatment

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fever
• Hyperthermia
• Hyperthermic Intraperitoneal Chemotherapy
• Ovarian Cancer
• Ovarian Neoplasms
• Paclitaxel

Intervention

Drug:
• Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
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. HIPEC was delivered immediately following the debulking surgery using the closed technique with a target temperature of 43 ? for 90 minutes.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital	Guangzhou	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-Limiting Toxicity	Grade 3 AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Event (CTC-AE) Version 4.0 classification are used to define DLT.	within 3 weeks following HIPEC