A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin in Patients With Advanced-stage Ovarian Cancer
Overview
- Phase
- Phase 1
- Intervention
- Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
- Conditions
- Ovarian Cancer
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Dose-Limiting Toxicity
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Jing Li
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
Arms & Interventions
Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
Patients with ovarian cancer receive hyperthermic intraperitoneal paclitaxel combined with a fixed dose of cisplatin (75mg/m2)
Intervention: Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
Outcomes
Primary Outcomes
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.