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

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ClinicalTrials.gov Identifier: NCT05620654
Recruitment Status : Recruiting
First Posted : November 17, 2022
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
Jing Li, 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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Hyperthermic Intraperitoneal Chemotherapy Paclitaxel Drug: Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Bayesian 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
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023


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.




Primary Outcome Measures :
  1. Dose-Limiting Toxicity [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05620654


Contacts
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Contact: Jing Li, MD 008602034071260 lijing228@mail.sysu.edu.cn

Locations
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China, Other (Non U.s.)
Sun Yat-sen Memorial Hospital Recruiting
Guangzhou, Other (Non U.s.), China, 510000
Contact: miaofang Wu    +8613828494674    wmiaofang@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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Responsible Party: Jing Li, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT05620654    
Other Study ID Numbers: 2021-KY-132
First Posted: November 17, 2022    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hyperthermia
Fever
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries
Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action