Phase I Trial HIPEC With Nal-irinotecan

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Stony Brook University
Study ID
NCT04088786
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nanoliposomal irinotecan — DRUG
    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.

Study Details

The purpose of this study is to assess the effectiveness and safety of intraperitoneal administration of heated nanoliposomal Irinotecan in cytoreductive surgery (CRS), which is surgery designed to remove as much of the cancer as possible, and heated intraperitoneal chemotherapy (HIPEC) procedures.

Key Dates

Start date
Oct 22, 2019
Status verified
May 2022
Primary completion
Oct 11, 2021
Completion
Apr 14, 2022

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Active
    Cytoreductive surgery (CRS) followed by study treatment with nanoliposomal irinotecan administered intraperitoneally.

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to 4 weeks post surgery ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536-
Stony Brook University Cancer CenterStony BrookNew York11794-

Find similar trials in Lexington, KY

By condition
Colorectal cancerGastric cancer
By specialty
OncologyGI oncology
By research site
University of Kentucky· Lexington, KYStony Brook University Cancer Center· Stony Brook, NY

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