Overview

Methylnaltrexone for Opioid-induced Constipation in Cancer Patients

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy of methylnaltrexone in relieving opioid-induced constipation in cancer patients at various stages of disease.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Vermont
Treatments:
Analgesics, Opioid
Bromides
Methylnaltrexone
Naltrexone
Criteria
Inclusion Criteria:

- Histologically or cytologically confirmed neoplasm

- 18 years of age or older

- Have received opioids for analgesia for at least 2 weeks and been on a stable regimen
of opioids and laxatives for 3 or more days before study entry

- Fewer than three laxation during the preceding week and no laxation within 24 hours
before study entry, or no laxation within 48 hours before study entry

- Life expectancy of at least 6 months

- World Health Organization Performance Status 0-3

- Women of childbearing potential must have a negative pregnancy test

- Breastfeeding should be discontinued prior to study entry

- Ability to understand and the willingness to sign a written informed consent document.

- Laboratory values within a week of study entry:

Absolute neutrophil count > 1,500/microliter Hemoglobin > 7 g/dL Platelet count >
100,000/microliter Calculated calcium < 10.5 mg/dL Calculated creatinine clearance > 30
mg.min Alanine aminotransferase < 3 x upper limit of normal (ULN) Aspartate
aminotransferase < 3 x ULN Alkaline phosphatase < 2.5 x ULN Bilirubin < 1.5 x ULN

Exclusion Criteria:

- Constipation not primarily caused by opioids, such as mechanical gastrointestinal
obstruction or ongoing vinca alkaloid administration

- Indwelling peritoneal catheter

- Clinically active diverticular disease

- Fecal impaction

- Acute surgical abdomen

- Fecal ostomy

- Peritoneal carcinomatosis

- Known hypersensitivity to methylnaltrexone, naltrexone, or naloxone

- Administration of any investigational drug or experimental product within the previous
30 days

- Initiation of a new bowel regimen or prokinetic agents within a week of study entry