Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension

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