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