Clinical trial NCT03352414: Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC
Official title: The ILEUS Study: A Phase 2 Randomized Controlled Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ileus
Keywords: HIPEC
peritoneal carcinomatosis
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Time to Return of Upper and Lower GI Function
timeFrame: from surgery to discharge (generally no longer than two weeks)
Secondary outcomes:
measure: Prolonged Ileus
timeFrame: from surgery to discharge (generally no longer than two weeks)
measure: Time to Return of Bowel Function Components
timeFrame: from surgery to discharge (generally no longer than two weeks)
measure: Time to Discharge
timeFrame: from surgery to discharge (generally no longer than two weeks)
measure: Serious Adverse Events
timeFrame: up to 30 days from surgery
measure: Subgroup Analyses
timeFrame: up to 30 days from surgery
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
Study officials:
affiliation: UCSD
name: Joel M Baumgartner, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baumgartner JM, Chen R, Messer K, Veerapong J, Kelly KJ, Ramamoorthy S, Lowy AM. Alvimopan for Enhanced Gastrointestinal Recovery after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: A Randomized Controlled Trial. J Am Coll Surg. 2022 Nov 1;235(5):693-701. doi: 10.1097/XCS.0000000000000305. Epub 2022 Oct 17.