Treatment of Cancer-anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients

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

Purpose of the study is to compare the effects of megestrol acetate concentrated suspension and placebo on caloric intake for the treatment of cancer-associated anorexia in patients 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