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

Sun Yat-sen University

Status and phase: Enrolling; Phase 1

Conditions: Hyperthermic Intraperitoneal Chemotherapy; Paclitaxel; Ovarian Cancer

Treatments: Drug: Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05620654

2021-KY-132

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin

Experimental group

Description:

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

Treatment:

Drug: Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin