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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Anorexia, Cachexia, Weight Loss

In brief

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

Key facts

Study ID

NCT00637728

Run by

Par Pharmaceutical, Inc.

People needed

5

Starts

2006-06-01

Expected to finish

2006-09-01

Last updated by the study team

2016-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Innovative Medical Research of South Florida, Inc — Miami, Florida, United States
• Western Maryland Health System — Cumberland, Maryland, United States
• Lowcountry Hematology & Oncology, PA — Mt. Pleasant, South Carolina, United States

Full record on ClinicalTrials.gov

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