Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2018 |
| Start Date: | March 8, 2018 |
| End Date: | March 2021 |
| Contact: | Joel M Baumgartner, MD, MAS |
| Email: | j1baumgartner@ucsd.edu |
| Phone: | (858) 246-0581 |
The ILEUS Study: A Phase 2 Randomized Controlled Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
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.
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.
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.
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.
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.
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