Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC

NCT03352414 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 171044
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileus

Keywords

HIPEC; peritoneal carcinomatosis

Outcome Measures

Primary Outcomes (1)

• 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.

  from surgery to discharge (generally no longer than two weeks)

Secondary Outcomes (5)

• Prolonged Ileus

  from surgery to discharge (generally no longer than two weeks)

• Time to Return of Bowel Function Components

  from surgery to discharge (generally no longer than two weeks)

• Time to Discharge

  from surgery to discharge (generally no longer than two weeks)

• Serious Adverse Events

  up to 30 days from surgery

• Subgroup Analyses

  up to 30 days from surgery

Study Arms (2)

Alvimopan

EXPERIMENTAL

alvimopan 12 mg PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge

Drug: Alvimopan

Placebo

PLACEBO COMPARATOR

Placebo pill PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge

Drug: Placebo

Interventions

Alvimopan DRUG

alvimopan pill

Also known as: Entereg

Alvimopan

Placebo DRUG

placebo pill

Also known as: Placebi

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Moores Cancer Center

La Jolla, California, 92093-0987, United States

Location

Related Publications (1)

• 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.

  PMID: 36102565 DERIVED

MeSH Terms

Conditions

Ileus; Peritoneal Neoplasms

Interventions

alvimopan

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Peritoneal Diseases

Results Point of Contact

• Title: Raymond Diep, Clinical Research Coordinator
• Organization: University of California, San Diego

rhdiep@health.ucsd.edu

(858) 822-5352

Study Officials

• Joel M Baumgartner, MD, MAS

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: November 18, 2017
• First Posted: November 24, 2017
• Study Start: March 8, 2018
• Primary Completion: April 28, 2020
• Study Completion: April 28, 2020
• Last Updated: August 18, 2021
• Results First Posted: July 1, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)