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

NCT ID: NCT05620654

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-05-01

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.

Conditions

Ovarian Cancer; Hyperthermic Intraperitoneal Chemotherapy; Paclitaxel

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin

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

Group Type: EXPERIMENTAL

Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Jing Li

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen Memorial Hospital

Guangzhou, Other (Non U.s.), China

Site Status: RECRUITING

Countries

China

Central Contacts

Jing Li, MD

Role: CONTACT

lijing228@mail.sysu.edu.cn

008602034071260

Facility Contacts

miaofang Wu

Role: primary

wmiaofang@mail.sysu.edu.cn

+8613828494674

Other Identifiers

2021-KY-132

Identifier Type: -

Identifier Source: org_study_id