This phase II trial studies how well alvimopan works in supporting gastrointestinal recovery in patients undergoing surgery to remove as many tumor cells from the affected area as possible (cytoreductive surgery) and infusion of a heated chemotherapy solution that circulates into the abdominal cavity (hyperthermic intraperitoneal chemotherapy). Alvimopan may help decrease the time to return to normal bowel function after surgery and hyperthermic intraperitoneal chemotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03352414.
PRIMARY OBJECTIVE:
I. To determine the efficacy of alvimopan to reduce postoperative ileus in patients undergoing cytoreductive surgery/hyperthermic intraperitoneal chemotherapy (CRS/HIPEC), as measured by the composite of time to recovery of upper and lower gastrointestinal (GI) function, as defined by the later of the following two events (GI-2): time that the patient first tolerates solid food and time that the patient first passes a bowel movement.
SECONDARY OBJECTIVES:
I. To determine the proportion of prolonged ileus (> 7 days) in each group.
II. To determine the time to return of bowel function components in each group: time to first flatus, time to first bowel movement, time to tolerance of solid food.
III. To determine the time to hospital discharge order written in each group.
IV. To measure the adverse event rate in each group.
V. To perform subgroup analyses on each group: 0 versus (vs.) 1 or greater anastomoses, 0 vs. 1 or greater visceral resection, high vs. low amount of postoperative narcotic use (above or below the median total postoperative morphine equivalent dose of narcotics), epidural vs. no epidural.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive alvimopan orally (PO) 30 minutes to 5 hours prior to surgery, and then twice a day (BID) after surgery until hospital discharge or up to 7 days in the absence of unacceptable toxicity.
GROUP II: Patients receive placebo PO 30 minutes to 5 hours prior to surgery, and then BID after surgery until hospital discharge or up to 7 days in the absence of unacceptable toxicity.
After discharge from the hospital, patients are followed for 30 days.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUC San Diego Medical Center - Hillcrest
Principal InvestigatorJoel Baumgartner
