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Trial Title:
A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
NCT ID:
NCT05620654
Condition:
Ovarian Cancer
Hyperthermic Intraperitoneal Chemotherapy
Paclitaxel
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hyperthermia
Fever
Paclitaxel
Cisplatin
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Bayesian Optimal Interval Design
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
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.
Arm group label:
Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
miaofang Wu
Phone:
+8613828494674
Email:
wmiaofang@mail.sysu.edu.cn
Start date:
December 1, 2022
Completion date:
May 1, 2023
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05620654
