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

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05620654
Collaborator
(none)
30
1
1
5
6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Bayesian Optimal Interval DesignBayesian Optimal Interval Design
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin in Patients With Advanced-stage Ovarian Cancer
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin

Patients with ovarian cancer receive hyperthermic intraperitoneal paclitaxel combined with a fixed dose of cisplatin (75mg/m2)

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-sen Memorial Hospital Guangzhou Other (Non U.s.) China 510000

Sponsors and Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jing Li, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT05620654
Other Study ID Numbers:
  • 2021-KY-132
First Posted:
Nov 17, 2022
Last Update Posted:
Nov 17, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2022