Accelerating Gastrointestinal Recovery

Brief Title

Accelerating Gastrointestinal Recovery

Official Title

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

Brief Summary

      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 Phase

Phase 3

Study Type

Interventional

Primary Outcome

Postoperative Length of Hospital Stay

Secondary Outcome

 Postoperative Ileus Incidence

Condition

Ovarian Cancer

Intervention

Alvimopan

Study Arms / Comparison Groups

 Alvimopan

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

January 2013

Completion Date

October 2015

Primary Completion Date

August 2015

Eligibility Criteria

        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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jamie Bakkum-Gamez, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01704651

Organization ID

12-004082

Responsible Party

Sponsor-Investigator

Study Sponsor

Jamie N. Bakkum-Gamez

Collaborators

 Cubist Pharmaceuticals LLC

Study Sponsor

Jamie Bakkum-Gamez, MD, Principal Investigator, Mayo Clinic

Verification Date

August 2016