Phase I Trial HIPEC With Nal-irinotecan
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04088786|
Recruitment Status : Completed
First Posted : September 13, 2019
Last Update Posted : May 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Peritoneal Cancer Pseudomyxoma Peritonei Mucinous Adenocarcinoma Mucinous Tumor Colorectal Cancer Gastric Cancer Primary Peritoneal Carcinoma Mesothelioma||Drug: nanoliposomal irinotecan||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a 3+3 dose-finding cohort design.|
|Masking:||None (Open Label)|
|Masking Description:||All eligible patients will be treated with the study drug.|
|Official Title:||Phase I Trial of Cytoreductive Surgery and Heated Intraperitoneal Chemotherapy With Nanoliposomal Irinotecan in Patients With Peritoneal Surface Malignancies|
|Actual Study Start Date :||October 22, 2019|
|Actual Primary Completion Date :||October 11, 2021|
|Actual Study Completion Date :||April 14, 2022|
Cytoreductive surgery (CRS) followed by study treatment with nanoliposomal irinotecan administered intraperitoneally.
Drug: nanoliposomal irinotecan
The starting dose of nal-IRI will be 70 mg/m2 (cohort level 1) applied for 30 min using a closed HIPEC technique following completion of cytoreductive surgery. If there is dose limiting toxicity (DLT) in cohort level 1, then the dose will be reduced the dosage of the next cohort to 50 mg/m2 (cohort level 0). If there is no DLT, the dose of nal-IRI will be increased to 140 mg/m2, 210 mg/m2 and 280 mg/m2 . If one of the patients experiences DLT, then the cohort will expand to 6 patients and accrual to the current dose level and dose escalation will stop if 2 or more patients experience a DLT at a given dose level.
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to 4 weeks post surgery ]To assess the safety and feasibility of administering nanoliposmal irinotecan intraperitoneally following cytoreductive surgery.
- Plasmatic dosages [ Time Frame: 48 hours ]Determine the correlation of intraperitoneal dosages of nanoliposomal irinotecan with plasma blood levels using pharmacokinetic analysis
- Disease Free survival [ Time Frame: 6 months ]Assess the efficacy of intraperitoneal administration of nanoliposomal irinotecan relating to disease free survival.
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): NCT04088786
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|United States, New York|
|Stony Brook University Cancer Center|
|Stony Brook, New York, United States, 11794|
|Principal Investigator:||Minsig Choi, MD||Stony Brook University|
|Principal Investigator:||Joseph Kim, MD||University of Kentucky|
|Principal Investigator:||Georgios Georgakis, MD||Stony Brook University|