Accelerating Gastrointestinal Recovery

Accelerating Gastrointestinal Recovery in Women Undergoing Staging and/or Debulking Surgery for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: A Randomized, Double-Blind, Placebo-Controlled Trial

This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
• Intervention / Treatment: Drug: Alvimopan; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria:

• Females at least 18 years of age
• Have an American Society of Anesthesiologists (ASA) Score of I to III
• Are consented for primary, interval, or secondary cytoreduction for ovarian, tubal, or peritoneal cancer
• Are scheduled to have their nasogastric tube removed before the first postoperative dose of study medication
• Are able to understand the study procedures, have agreed to participate in the study program, and have voluntarily provided informed consent

Exclusion criteria:

• Females younger than 18 years of age
• Known non-gynecologic malignancy presenting with similar signs/symptoms as ovarian, tubal, or peritoneal cancer.
• Have taken more than 7 consecutive days of therapeutic doses of opioids immediately prior to surgery
• Use illicit drugs or abuse alcohol
• Have had a prior total colectomy, gastrectomy, gastric bypass, or have a functional colostomy or ileostomy
• Have an ongoing history of short bowel syndrome, chronic constipation (≤3 spontaneous bowel movements per week) or chronic diarrhea
• Have received radiation therapy to the abdomen or pelvis within 3 months of scheduled surgery
• Have chemotherapy or radiation induced bowel dysfunction
• Are pregnant (identified by a positive urine or serum pregnancy test) or lactating, or are not postmenopausal (no menses for at least 1 year) and are of childbearing potential and not using an accepted method of birth control (ie, surgical sterilization, intrauterine contraceptive device, oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam, or abstinence)
• Have participated in another investigational drug or medical device study within 30 days of surgery or will be enrolled in another investigational drug or medical device study or any study in which active patient participation is required outside normal hospital data collection during the course of this study
• Have clinically significant laboratory abnormalities at screening that would result in the cancellation of surgery
• Have a diagnosis of severe hepatic insufficiency or end stage renal disease.
• Have a history of previous surgeries, illness, or behavior that in the opinion of the investigator might confound the study results or pose additional risk in administering the study procedures
• Are unable to understand the study procedures and are not able to voluntarily provided informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alvimopan; Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.	Drug: Alvimopan; Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.; Other Names: Entereg
Placebo Comparator: Placebo; Perioperative administration of placebo, at same dosing interval as study drug.	Drug: Placebo; Perioperative administration of placebo, at same dosing interval as study drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Length of Hospital Stay	Length of stay = date/time of hospital dismissal - date/time of end of surgery	Patients will be followed for the duration of their hospital stay, an expected average of 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Ileus Incidence	Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.	Patients will be followed for 30 days postop

Collaborators and Investigators

• Sponsor: Jamie N. Bakkum-Gamez
• Collaborators: Cubist Pharmaceuticals LLC
• Investigators: Principal Investigator: Jamie Bakkum-Gamez, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 7, 2012
• First Submitted That Met QC Criteria: October 10, 2012
• First Posted (Estimate): October 11, 2012

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: August 30, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Cancer; Female; Ovary; Ovarian; Peritoneal; Fallopian; Gynecological
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Adnexal Diseases; Fallopian Tube Diseases; Fallopian Tube Neoplasms; Gastrointestinal Agents; Alvimopan
• Other Study ID Numbers: 12-004082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided