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

Ileus Clinical Trial

— ILEUS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03352414
• Other study ID #: 171044
• Status: Terminated
• Phase: Phase 2
• Start date: March 8, 2018
• Est. completion date: April 28, 2020

Study information

• Verified date: July 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: April 28, 2020
• Est. primary completion date: April 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ileus

Intervention

Drug:
• Alvimopan
alvimopan pill
• Placebo
placebo pill

Locations

Country	Name	City	State
United States	UCSD Moores Cancer Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Return of Upper and Lower GI Function	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	Prolonged Ileus	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)
Secondary	Time to Return of Bowel Function Components	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)
Secondary	Time to Discharge	The time from surgery until discharge order written.	from surgery to discharge (generally no longer than two weeks)
Secondary	Serious Adverse Events	The number and proportion of serious adverse events.	up to 30 days from surgery
Secondary	Subgroup Analyses	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