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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Ileus

In brief

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.

Key facts

Study ID

NCT03352414

Run by

University of California, San Diego

People needed

84

Starts

2018-03-08

Expected to finish

2020-04-28

Last updated by the study team

2021-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCSD Moores Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.