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