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Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (ILEUS)

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ClinicalTrials.gov Identifier: NCT03352414
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Joel Baumgartner, University of California, San Diego

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ileus Drug: Alvimopan Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The ILEUS Study: A Phase 2 Randomized Controlled Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Drug Information available for: Alvimopan

Arm Intervention/treatment
Experimental: Alvimopan Drug: Alvimopan
alvimopan pill
Other Name: Entereg

Placebo Comparator: Placebo Drug: Placebo
placebo pill




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Time to discharge [ Time Frame: from surgery to discharge (generally no longer than two weeks) ]
    The time from surgery until discharge order written.

  4. Adverse events [ Time Frame: up to 30 days from surgery ]
    The number and proportion of adverse events.

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT03352414


Contacts
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Contact: Joel M Baumgartner, MD, MAS (858) 246-0581 j1baumgartner@ucsd.edu

Locations
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United States, California
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093-0987
Contact: Joel M Baumgartner, MD, MAS    858-246-0581    j1baumgartner@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Joel M Baumgartner, MD, MAS UCSD

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Responsible Party: Joel Baumgartner, Assistant Professor of Surgery, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03352414     History of Changes
Other Study ID Numbers: 171044
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Joel Baumgartner, University of California, San Diego:
HIPEC
peritoneal carcinomatosis

Additional relevant MeSH terms:
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Ileus
Fever
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Body Temperature Changes
Signs and Symptoms
Alvimopan
Gastrointestinal Agents