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Peritoneal CancerPhase 1NCT04088786

Phase I Trial HIPEC With Nal-irinotecan

A Phase 1 study testing nanoliposomal irinotecan in people with Peritoneal Cancer and Pseudomyxoma Peritonei, run by Stony Brook University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
nanoliposomal irinotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesUnited States
Study dates
22 Oct 2019to 14 Apr 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with pseudomyxoma peritonei or peritoneal carcinomatosis of digestive origin or primary peritoneum: appendiceal mucinous tumor or adenocarcinoma (including goblet cell cancer and signet ring cell cancer), colorectal cancer, gastric cancer, primary peritoneal adenocarcinoma, and mesothelioma; regardless of the number of prior treatment lines. Diagnosis of peritoneal metastasis to be confirmed via either clinical or histopathology assessment.
  • Age ≥18 years
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Patients must be candidates for grossly complete cytoreduction surgery with life expectancy greater than 3 months
  • Patients must have normal organ and marrow function as defined below:
  • absolute neutrophil count >1,500/microliter (mcL) and white blood cells > 4000/mm3
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  • platelets >75,000/microliters
  • total bilirubin < 3x upper limit normal for institutional limits
  • aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) <2.5x institutional upper limit of normal
  • creatinine within normal institutional limits
  • Documentation of resectable disease extent by radiographic peritoneal carcinomatosis index (PCI) score or preoperative diagnostic surgery/laparoscopy with preoperative measurements taken within 6 weeks of study entry.
  • Women of child-bearing potential and men must agree to use adequate contraception (barrier or hormonal plus barrier method of birth control; abstinence) prior to study entry and for the duration of study participation (at least first 6 months). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patients with peritoneal disease considered to be unresectable according to preoperative clinical criteria.
  • Patients who undergo debulking for palliation with persistence of gross residual disease (complete of cytoreduction score 3, CC=3) will be ineligible for the study.
  • Large burden visceral metastases or extra-abdominal metastases.
  • Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. There is no limit on the number of prior lines of chemotherapy.
  • Patients may not be receiving any other investigational agents.
  • History of allergic reactions to nal-IRI or irinotecan.
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  • 7 Uncontrolled ongoing illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • 8 Pregnant or breast-feeding women are excluded from this study.
  • 9 HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Stony Brook University Cancer Center

    Stony Brook, New York, 11794

Other trials in United States

About this study

Official title: Phase I Trial of Cytoreductive Surgery and Heated Intraperitoneal Chemotherapy With Nanoliposomal Irinotecan in Patients With Peritoneal Surface Malignancies

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.

Read the detailed 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. 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.

Being tested
nanoliposomal irinotecan
Keywords
HIPEC, nal-irinotecan
Medical subject headings
Pseudomyxoma Peritonei, Adenocarcinoma, Mucinous, Neoplasms, Cystic, Mucinous, and Serous, Colorectal Neoplasms, Stomach Neoplasms, Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nanoliposomal irinotecanDrug

    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 groups in NCT04088786
Study groupRoleWhat they receive
ActiveExperimentalCytoreductive surgery (CRS) followed by study treatment with nanoliposomal irinotecan administered intraperitoneally.
Receives: Drug: nanoliposomal irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    To assess the safety and feasibility of administering nanoliposmal irinotecan intraperitoneally following cytoreductive surgery.

    Measured: Up to 4 weeks post surgery

Secondary outcomes (2)

  1. Plasmatic dosages

    Determine the correlation of intraperitoneal dosages of nanoliposomal irinotecan with plasma blood levels using pharmacokinetic analysis

    Measured: 48 hours

  2. Disease Free survival

    Assess the efficacy of intraperitoneal administration of nanoliposomal irinotecan relating to disease free survival.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2019
  2. Study start22 Oct 2019
  3. Primary completion11 Oct 2021
  4. Study completion14 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a 3+3 dose-finding cohort design.
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04088786
Sponsor's protocol ID
2019-00059 HIPEC Nal-IRI
Other IDs
2019
Status last verified
May 2022
First submitted
11 Sep 2019
Last updated
6 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • McDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3.

    PubMed 36410913

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing nanoliposomal irinotecan in people with Peritoneal Cancer and Pseudomyxoma Peritonei, run by Stony Brook University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04088786, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.

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