Status:
TERMINATED
Treatment of Cancer-anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients
Lead Sponsor:
Par Pharmaceutical, Inc.
Collaborating Sponsors:
PRA Health Sciences
Conditions:
Anorexia
Cachexia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 pancr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00637728
Start Date
June 1 2006
End Date
September 1 2006
Last Update
June 23 2016
Active Locations (3)
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1
Innovative Medical Research of South Florida, Inc
Miami, Florida, United States, 33179
2
Western Maryland Health System
Cumberland, Maryland, United States, 21502
3
Lowcountry Hematology & Oncology, PA
Mt. Pleasant, South Carolina, United States, 29464