- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03352414
Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC (ILEUS)
The ILEUS Study: A Phase 2 Randomized Controlled Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Study Overview
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). 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
La Jolla, California, United States, 92093-0987
- UCSD Moores Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alvimopan
alvimopan 12 mg PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge
|
alvimopan pill
Other Names:
|
Placebo Comparator: Placebo
Placebo pill PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge
|
placebo pill
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Return of Upper and Lower GI Function
Time Frame: from surgery to discharge (generally no longer than two weeks)
|
The later of the time from surgery that the participant first tolerates solid food and the time that the participant first passes a bowel movement.
|
from surgery to discharge (generally no longer than two weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prolonged Ileus
Time Frame: from surgery to discharge (generally no longer than two weeks)
|
The proportion of patients who do not pass flatus or bowel movement greater than 7 days from the time of surgery.
|
from surgery to discharge (generally no longer than two weeks)
|
Time to Return of Bowel Function Components
Time Frame: from surgery to discharge (generally no longer than two weeks)
|
The time from surgery until:
|
from surgery to discharge (generally no longer than two weeks)
|
Time to Discharge
Time Frame: from surgery to discharge (generally no longer than two weeks)
|
The time from surgery until discharge order written.
|
from surgery to discharge (generally no longer than two weeks)
|
Serious Adverse Events
Time Frame: up to 30 days from surgery
|
The number and proportion of serious adverse events.
|
up to 30 days from surgery
|
Subgroup Analyses
Time Frame: up to 30 days from surgery
|
All primary and secondary outcomes will be measured in the following subgroups:
|
up to 30 days from surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Joel M Baumgartner, MD, MAS, UCSD
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 171044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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