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

Phase 1

Recruiting

• Conditions: Paclitaxel; Ovarian Cancer; Hyperthermic Intraperitoneal Chemotherapy
• Interventions: Drug: Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin

• Registration Number: NCT05620654
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-11-11
• Last Update Submitted: 2022-11-11
• Study First Posted: 2022-11-17
• Last Update Posted: 2022-11-17
• Study Start: 2022-12-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin	Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin	Patients with ovarian cancer receive hyperthermic intraperitoneal paclitaxel combined with a fixed dose of cisplatin (75mg/m2)

Primary Outcome Measures

Name	Time	Method
Dose-Limiting Toxicity	within 3 weeks following HIPEC	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.

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital; 🇨🇳 Guangzhou, Other (Non U.s.), China