A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
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|ClinicalTrials.gov Identifier: NCT05620654|
Recruitment Status : Recruiting
First Posted : November 17, 2022
Last Update Posted : November 17, 2022
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|
|Ovarian Cancer Hyperthermic Intraperitoneal Chemotherapy Paclitaxel||Drug: Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Bayesian Optimal Interval Design|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin in Patients With Advanced-stage Ovarian Cancer|
|Estimated Study Start Date :||December 1, 2022|
|Estimated Primary Completion Date :||May 1, 2023|
|Estimated Study Completion Date :||May 1, 2023|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05620654
|Contact: Jing Li, MDfirstname.lastname@example.org|
|China, Other (Non U.s.)|
|Sun Yat-sen Memorial Hospital||Recruiting|
|Guangzhou, Other (Non U.s.), China, 510000|
|Contact: miaofang Wu +8613828494674 email@example.com|