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

Primary Purpose

Ovarian Cancer, Hyperthermic Intraperitoneal Chemotherapy, Paclitaxel

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2022
Last Updated
November 11, 2022
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05620654
Brief Title
A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
Official Title
A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin in Patients With Advanced-stage Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Hyperthermic Intraperitoneal Chemotherapy, Paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Bayesian Optimal Interval Design
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
Arm Type
Experimental
Arm Description
Patients with ovarian cancer receive hyperthermic intraperitoneal paclitaxel combined with a fixed dose of cisplatin (75mg/m2)
Intervention Type
Drug
Intervention Name(s)
Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dose-Limiting Toxicity
Description
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.
Time Frame
within 3 weeks following HIPEC

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Li, MD
Phone
008602034071260
Email
lijing228@mail.sysu.edu.cn
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital
City
Guangzhou
State/Province
Other (Non U.s.)
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
miaofang Wu
Phone
+8613828494674
Email
wmiaofang@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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