IleusPhase 2ILEUSNCT03352414
Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC
A Phase 2 study testing Alvimopan in people with Ileus, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileus
- What is being tested?
- Alvimopan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2018to 28 Apr 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Moores Cancer Center
La Jolla, California, 92093-0987
About this study
Official title: 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.
Read the 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.
- Conditions
- Ileus
- Being tested
- Alvimopan, Placebo
- Keywords
- HIPEC, peritoneal carcinomatosis
- Medical subject headings
- Ileus, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlvimopanDrug
Also called Entereg
alvimopan pill
PlaceboDrug
Also called Placebi
placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Alvimopan | Experimental | alvimopan 12 mg PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge Receives: Drug: Alvimopan |
| Placebo | Placebo comparator | Placebo pill PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from surgery to discharge (generally no longer than two weeks)
Secondary outcomes (5)
Prolonged Ileus
The proportion of patients who do not pass flatus or bowel movement greater than 7 days from the time of surgery.
Measured: from surgery to discharge (generally no longer than two weeks)
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
Measured: from surgery to discharge (generally no longer than two weeks)
Time to Discharge
The time from surgery until discharge order written.
Measured: from surgery to discharge (generally no longer than two weeks)
Serious Adverse Events
The number and proportion of serious adverse events.
Measured: up to 30 days from surgery
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
Measured: up to 30 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start8 Mar 2018
- Primary completion28 Apr 2020
- Study completion28 Apr 2020
Why it stopped: stopped by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IleusStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Baumgartner, University of California, San Diego
- Investigators
- Joel M Baumgartner, MD, MAS, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352414
- Sponsor's protocol ID
- 171044
- Acronym
- ILEUS
- Status last verified
- Jul 2021
- First submitted
- 18 Nov 2017
- Last updated
- 18 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Study was terminated early
Publications
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.
PubMed 36102565
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ILEUS Study: A Phase 2 Randomized Controlled Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
- ClinicalTrials.gov ID
- NCT03352414
- Acronym / sponsor ID
- ILEUS / 171044
- Conditions
- Ileus
- Keywords
- HIPEC, peritoneal carcinomatosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: stopped by sponsor
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Posted 1 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alvimopan | Experimental | Drug: Alvimopanalvimopan 12 mg PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pill PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlvimopanAlso: Enteregalvimopan pill | Drug | Alvimopan |
| PlaceboAlso: Placebiplacebo pill | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
Prolonged Ileus
Time frame: 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)
Time to Discharge
Time frame: from surgery to discharge (generally no longer than two weeks)
Serious Adverse Events
Time frame: up to 30 days from surgery
Subgroup Analyses
Time frame: up to 30 days from surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36102565Baumgartner 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.
- Individual participant dataSharing planned: No. Study was terminated early
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel M Baumgartner, MD, MAS principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alvimopan in people with Ileus, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Return of Upper and Lower GI Function (time frame: from surgery to discharge (generally no longer than two weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03352414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.