Back to resultsPhase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC (ILEUS)
Primary Purpose
Ileus
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Alvimopan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ileus focused on measuring HIPEC, peritoneal carcinomatosis
Eligibility Criteria
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.
Sites / Locations
- UCSD Moores Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Alvimopan
Placebo
Arm Description
alvimopan 12 mg PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge
Placebo pill PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge
Outcomes
Primary Outcome Measures
Time to Return of Upper and Lower GI Function
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.
Secondary Outcome Measures
Prolonged Ileus
The proportion of patients who do not pass flatus or bowel movement greater than 7 days from the time of surgery.
Time to Return of Bowel Function Components
The time from surgery until:
The time to first flatus
The time to first bowel movement
The time to tolerance of solid food
Time to Discharge
The time from surgery until discharge order written.
Serious Adverse Events
The number and proportion of serious adverse events.
Subgroup Analyses
All primary and secondary outcomes will be measured in the following subgroups:
0 vs. 1 or greater bowel anastomoses
0 vs. 1 or greater visceral resections
high vs. low amount of postoperative opioid use
epidural vs. no epidural
Full Information
NCT ID
NCT03352414
First Posted
November 18, 2017
Last Updated
July 19, 2021
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT03352414
Brief Title
Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC
Acronym
ILEUS
Official Title
The ILEUS Study: A Phase 2 Randomized Controlled Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
stopped by sponsor
Study Start Date
March 8, 2018 (Actual)
Primary Completion Date
April 28, 2020 (Actual)
Study Completion Date
April 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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 chemotherapy. Half of the participants will receive alvimopan or and half will receive placebo immediately before and for up to seven days after surgery.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus
Keywords
HIPEC, peritoneal carcinomatosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alvimopan
Arm Type
Experimental
Arm Description
alvimopan 12 mg PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pill PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge
Intervention Type
Drug
Intervention Name(s)
Alvimopan
Other Intervention Name(s)
Entereg
Intervention Description
alvimopan pill
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebi
Intervention Description
placebo pill
Primary Outcome Measure Information:
Title
Time to Return of Upper and Lower GI Function
Description
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.
Time Frame
from surgery to discharge (generally no longer than two weeks)
Secondary Outcome Measure Information:
Title
Prolonged Ileus
Description
The proportion of patients who do not pass flatus or bowel movement greater than 7 days from the time of surgery.
Time Frame
from surgery to discharge (generally no longer than two weeks)
Title
Time to Return of Bowel Function Components
Description
The time from surgery until:
The time to first flatus
The time to first bowel movement
The time to tolerance of solid food
Time Frame
from surgery to discharge (generally no longer than two weeks)
Title
Time to Discharge
Description
The time from surgery until discharge order written.
Time Frame
from surgery to discharge (generally no longer than two weeks)
Title
Serious Adverse Events
Description
The number and proportion of serious adverse events.
Time Frame
up to 30 days from surgery
Title
Subgroup Analyses
Description
All primary and secondary outcomes will be measured in the following subgroups:
0 vs. 1 or greater bowel anastomoses
0 vs. 1 or greater visceral resections
high vs. low amount of postoperative opioid use
epidural vs. no epidural
Time Frame
up to 30 days from surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel M Baumgartner, MD, MAS
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0987
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study was terminated early
Citations:
PubMed Identifier
36102565
Citation
Baumgartner JM, Chen R, Messer K, Veerapong J, Kelly KJ, Ramamoorthy S, Lowy AM. Alvimopan for Enhanced Gastrointestinal Recovery after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: A Randomized Controlled Trial. J Am Coll Surg. 2022 Nov 1;235(5):693-701. doi: 10.1097/XCS.0000000000000305. Epub 2022 Oct 17.
Results Reference
derived
Learn more about this trial
Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC
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