Back to resultsA 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
About this trial
This is an interventional treatment trial for Ovarian Cancer
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
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
NCT ID
NCT05620654
First Posted
November 11, 2022
Last Updated
November 11, 2022
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
Learn more about this trial
A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
We'll reach out to this number within 24 hrs