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

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

Summary

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

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

Details

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

Criteria

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