Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Gastrointestinal Agents

All Drugs and Chemicals

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.

Perioperative administration of placebo, at same dosing interval as study drug.

Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.

Placebo

Jamie Bakkum-Gamez, MD

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.

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

Length of stay = date/time of hospital dismissal - date/time of end of surgery

Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Jamie N. Bakkum-Gamez

Consultant and Assistant Professor of Obstetrics-Gynecology,

Perioperative administration of oral placebo, at same dosing interval as study drug, starting with one dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days..

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Primary surgery

Interval debulking

Secondary debulking

Surgery Type

I/II

III/IV

Other non-ovarian primary cancers

Benign pelvic masses

Recurrent disease

Cancer Stage used the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system. For ovarian cancer, there are 4 stages: stage I: confined to the organ of origin, stage II: invasion of surrounding organs or tissue, stage III: spread to distant nodes or tissue within the pelvis, stage IV: distant metastasis(es)

Cancer Stage

Yes, measurable (</= 1 cm)

Yes, suboptimal (>1 cm, limited sites)

Yes, extensive (multiple sites/organs)

Residual Disease

Baseline characteristics are provided for the subjects who completed study follow up.

Dr. Jamie N. Bakkum-Gamez

Postoperative Length of Hospital Stay

Postoperative Ileus Incidence

Overall Study

Spots Global Cancer Trial Database for Accelerating Gastrointestinal Recovery

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial