Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension

• Status: Terminated
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Par Pharmaceutical, Inc.
• Collaborator: PRA Health Sciences
• Treatments: Megestrol; Megestrol Acetate

Criteria

Inclusion Criteria:

• Cancer of multiple types in stage II, III, or IV and not a candidate for chemotherapy; but may have been receiving radiation therapy

• Fair, poor, or very poor appetite

• Cancer-associated anorexia/cachexia (documented weight loss of 2% over the prior week, or at least 5% within past 30 days, or at least 7.5% over prior 3 months, or at least 10% over prior 6 months)

• Weight loss perceived to be associated with diminished appetite

• Eastern Cooperative Oncology Group Performance score of 0, 1, or 2

• Life expectancy greater than 3 months

• Alert and mentally competent to complete study assessments

• Women of child-bearing potential required to use an adequate and reliable method of contraception. Post-menopausal women have to have been so for at least 1 year

• Screening laboratory values must not be clinically significant (some exceptions per protocol)

Exclusion Criteria:

• Brain, or head and neck tumors that may interfere with food consumption

• AIDS-related wasting

• Radiation therapy to head and neck, abdomen, or pelvis within past 6 weeks, or for whom radiation therapy is anticipated during the study such that the result may interfere with food consumption

• Presence of conditions that interfere with oral intake or ability to swallow

• Absence of normally functioning gut

• Known mechanical obstruction of the alimentary or biliary tract, or malabsorption syndrome

• Intractable or frequent vomiting

• Clinically significant diarrhea

• History of thromboembolic events, or on long-term anticoagulation for thromboembolism

• Uncontrolled diabetes mellitus, or symptomatic hypoadrenalism

• Poorly controlled hypertension or congestive heart failure

• Pregnant/lactating females, or planning on becoming pregnant

• Use of appetite stimulants within past 30 days

• Use of parenteral nutrition or tube feedings within past 1 week

• Chronic use of steroids within past 3 months (intermittent short-term use allowed)

• Current use of illicit substances

• Allergy, hypersensitivity, or other contraindication to megestrol acetate