A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
Study Details
Study Description
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 |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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Outcome Measures
Primary Outcome Measures
- Dose-Limiting Toxicity [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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age between 18 and 65 years;
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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:
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Patients who had been treated with cisplatin OR paclitaxel for any reason within 3 weeks prior to HIPEC.
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A history of HIPEC treatment
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Sun Yat-sen Memorial Hospital | Guangzhou | Other (Non U.s.) | China | 510000 |
Sponsors and Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-KY-132