Status:
TERMINATED
Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC
Lead Sponsor:
University of California, San Diego
Conditions:
Ileus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 chemot...
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)....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2020
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03352414
Start Date
March 8 2018
End Date
April 28 2020
Last Update
August 18 2021
Active Locations (1)
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1
UCSD Moores Cancer Center
La Jolla, California, United States, 92093-0987