A Randomized, Double-Blind, Placebo-Controlled Study of Megestrol Acetate Concentrated Suspension for the Treatment of Cancer-Associated Anorexia in Subjects With Lung or Pancreatic Cancer
Inclusion Criteria:
- Stage II, III,or IV lung or pancreatic cancer
- Fair, poor, or very poor appetite
- Cancer associated anorexia/cachexia
- Weight loss perceived to be associated with diminished appetite
- Eastern Cooperative Oncology Group Performance score of 0, 1, 2
- Life expectancy >3 months
- Alert and mentally competent
- 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 metastases that may interfere with food consumption
- AIDS-related wasting
- Radiation therapy to the head and neck, abdomen, or pelvis within past 6 weeks, or
anticipated during course of the study such that the result may interfere with food
consumption
- Conditions that interfere with oral intake, or ability to swallow
- Absence of a normally functioning gut
- Mechanical obstruction of the alimentary or biliary tract, or malabsorption syndrome
- Intractable or frequent vomiting that regularly interfere with eating
- Clinically significant diarrhea
- History of recurrent thromboembolic events, a thromboembolic event in past 3 months,
or long-term anticoagulation treatment for thromboembolism
- Uncontrolled diabetes mellitus, or symptomatic hypoadrenalism
- Poorly controlled hypertension, or congestive heart failure
- Pregnant/lactating females
- Use within past 30 days of an appetite stimulant
- Use within past week, or planned use during the study of parenteral nutrition or tube
feedings
- Chronic use of steroids within past 3 months (intermittent short-term use allowed)
- Current use of or not willing to abstain from using illicit substances
- Allergy, hypersensitivity, or contraindication to megestrol acetate