A phase I dose-finding trial of hyperthermic intraperitoneal docetaxel combined with cisplatin in patients with advanced-stage ovarian cancer.

Authors

Jing Li

Jing Li

Department of Gynecology, Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Shanwei, Guangdong., China

Jing Li , Zhi-yao You , Miao-fang Wu , Zhong-qiu Lin , Qing Chen

Organizations

Department of Gynecology, Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Shanwei, Guangdong., China, Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Guangzhou, China, Department of Gynecologic Oncology, Yat-sen Memorial Hospital of SunYat-sen University, Guangzhou, China, Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China

Research Funding

Institutional Funding
Sun Yat-Sen Clinical Research Cultivating Program (SYS-Q-202203, SYS-Q-202207), Guangdong Basic and Applied Basic Research Foundation (2021A1515111177, 2021A1515220142)

Background: To identify the maximum tolerated dose (MTD) of docetaxel combined with a fixed dose of cisplatin (75 mg/m2) delivered as hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian cancer. Methods: In this single-center Phase I trial, time-to-event Bayesian Optimal Interval Design (TITE-BOIN) was used. The starting dose for docetaxel was 60 mg/m2, with escalation in 5 mg/m2 increments until the MTD was determined or the maximum dose level of 75 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. Results: A total of 30 patients were enrolled from August 2022 to November 2022. Among patients who received a docetaxel dose level ≤ 65 mg/m2, no DLT was reported. DLTs were observed in one patient at 70mg/m2 docetaxel (grade 3 anemia) and three patients at 75mg/m2 docetaxel (one grade 3 anemia, one grade 3 hepatic impairment and one grade 4 thrombocytopenia). When patients were treated with docetaxel at a dose of 75 mg/m2 in combination with 75 mg/m2 cisplatin, the estimated DLT rate was 25% which was closest to the target DLT rate and therefore selected as the MTD. Conclusions: For ovarian cancer patients who receive HIPEC following debulking surgery, docetaxel, in combination with a fixed dose of cisplatin (75 mg/m2), can be safely used at intraperitoneal doses of 75 mg/m2(ClinicalTrials.gov identifier, NCT05410483).

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr e17532)

DOI

10.1200/JCO.2023.41.16_suppl.e17532

Abstract #

e17532

Abstract Disclosures