Accelerating Gastrointestinal Recovery
Condition: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
MeSH terms: Fallopian Tube Neoplasms
Intervention: Alvimopan; Placebo
Intervention description: Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.; Perioperative administration of placebo, at same dosing interval as study drug.
Intervention MeSH terms: Alvimopan
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 146.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovary; Ovarian; Fallopian; Peritoneal; Cancer; Gynecological; Female

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.
    

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