Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC (ILEUS)

July 19, 2021 updated by: Joel Baumgartner, University of California, San Diego

The ILEUS Study: A Phase 2 Randomized Controlled Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

The purpose of this study is to investigate the ability of alvimopan to reduce the time to return of bowel function in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Half of the participants will receive alvimopan or and half will receive placebo immediately before and for up to seven days after surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a surgical procedure to treat cancer that has spread to the lining of the abdominal cavity (peritoneal metastases). It is associated with a prolonged time for return of bowel function after surgery.

Alvimopan is a drug used to speed up the time for return of bowel function after surgery. It works by blocking the opioid receptors in the gastrointestinal tract, which normally slow down bowel function in patients receiving postoperative opioid pain medication. It has not previously been tested in patients undergoing CRS/HIPEC.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • La Jolla, California, United States, 92093-0987
        • UCSD Moores Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to understand and the willingness to sign a written informed consent.
  • Scheduled to undergo open (non-minimally invasive) CRS/HIPEC.
  • Scheduled to receive postoperative pain management with intravenous opioids.
  • Age > 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
  • Women of child-bearing potential with negative pregnancy test prior to initiating study drug dosing.

Exclusion Criteria:

  • Greater than 7 days of consecutive opioid use immediately prior to scheduled surgery.
  • Child-Pugh Class C hepatic impairment.
  • End-stage renal disease (GFR < 15 mL/min/1.73 m2 and/or on peritoneal dialysis or hemodialysis).
  • Complete mechanical bowel obstruction.
  • Contraindication or inability to tolerate oral medication postoperatively.
  • Presence of gastrointestinal ostomy after CRS/HIPEC.
  • Pancreatic or gastric anastomosis performed during CRS/HIPEC.
  • History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition as alvimopan at the treating investigators discretion.
  • Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e. uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).
  • History of myocardial infarction in the 12 months prior to scheduled surgery.
  • Pregnant or nursing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alvimopan
alvimopan 12 mg PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge
alvimopan pill
Other Names:
  • Entereg
Placebo Comparator: Placebo
Placebo pill PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge
placebo pill
Other Names:
  • Placebi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Return of Upper and Lower GI Function
Time Frame: from surgery to discharge (generally no longer than two weeks)
The later of the time from surgery that the participant first tolerates solid food and the time that the participant first passes a bowel movement.
from surgery to discharge (generally no longer than two weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prolonged Ileus
Time Frame: from surgery to discharge (generally no longer than two weeks)
The proportion of patients who do not pass flatus or bowel movement greater than 7 days from the time of surgery.
from surgery to discharge (generally no longer than two weeks)
Time to Return of Bowel Function Components
Time Frame: from surgery to discharge (generally no longer than two weeks)

The time from surgery until:

  • The time to first flatus
  • The time to first bowel movement
  • The time to tolerance of solid food
from surgery to discharge (generally no longer than two weeks)
Time to Discharge
Time Frame: from surgery to discharge (generally no longer than two weeks)
The time from surgery until discharge order written.
from surgery to discharge (generally no longer than two weeks)
Serious Adverse Events
Time Frame: up to 30 days from surgery
The number and proportion of serious adverse events.
up to 30 days from surgery
Subgroup Analyses
Time Frame: up to 30 days from surgery

All primary and secondary outcomes will be measured in the following subgroups:

  • 0 vs. 1 or greater bowel anastomoses
  • 0 vs. 1 or greater visceral resections
  • high vs. low amount of postoperative opioid use
  • epidural vs. no epidural
up to 30 days from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joel M Baumgartner, MD, MAS, UCSD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2018

Primary Completion (Actual)

April 28, 2020

Study Completion (Actual)

April 28, 2020

Study Registration Dates

First Submitted

November 18, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Study was terminated early

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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