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

University of California San Diego

Status and phase

Terminated

Phase 2

Conditions

Ileus

Treatments

Drug: Placebo

Drug: Alvimopan

Study type

Interventional

Funder types

Other

Identifiers

NCT03352414

171044

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.