Phase I Trial HIPEC With Nal-irinotecan
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colorectal Cancer
- Gastric Cancer
- Mesothelioma
- Mucinous Adenocarcinoma
- Mucinous Tumor
- Peritoneal Cancer
- Primary Peritoneal Carcinoma
- Pseudomyxoma Peritonei
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Cytoreductive surgery and heated intraperitoneal chemotherapy consists of two parts: the first is the surgical removal of all grossly visible deposits of cancer from the abdomen; and the second is application of heated chemotherapy in salt water at the same time as the removal of the visible cancer....
Cytoreductive surgery and heated intraperitoneal chemotherapy consists of two parts: the first is the surgical removal of all grossly visible deposits of cancer from the abdomen; and the second is application of heated chemotherapy in salt water at the same time as the removal of the visible cancer. HIPEC is an alternative method of delivering chemotherapy. Traditional chemotherapy is injected into a vein, while HIPEC applies chemotherapy drugs warmed up by an FDA-approved machine to 108 degrees Fahrenheit directly into the abdomen during surgery, making it an option for cancers that originated in or have spread to the abdominal cavity. Standard treatment in this manner usually includes Mitomycin C or Cisplatin as its chemotherapy agents. In this study, the investigators will use nanoliposomal irinotecan as the chemotherapy agent. Irinotecan is FDA approved for the treatment of pancreatic cancer.
Tracking Information
- NCT #
- NCT04088786
- Collaborators
- Ipsen
- Barbara Ann Karmanos Cancer Institute
- University of Iowa
- Investigators
- Principal Investigator: Minsig Choi, MD Stony Brook University Principal Investigator: Joseph Kim, MD University of Kentucky Principal Investigator: Georgios Georgakis, MD Stony Brook University
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