Accelerating Gastrointestinal Recovery

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704651
• Other study ID #: 12-004082
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2012
• Last updated: October 30, 2015
• Start date: January 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cancer

Intervention

Drug:
• Alvimopan
Perioperative administration of oral alvimopan
• Placebo
Perioperative administration of placebo

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Jamie N. Bakkum-Gamez	Cubist Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative length of hospital stay		Patients will be followed for the duration of their hospital stay, an expected average of 5 days	No
Secondary	Postoperative ileus incidence		Patients will be followed for 30 days postop	No