Treatment of Cancer-Anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients
Information source: Par Pharmaceutical, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anorexia; Cachexia; Weight Loss
Intervention: Megestrol acetate concentrated suspension 110 mg/mL (Drug); Placebo (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Par Pharmaceutical, Inc. Official(s) and/or principal investigator(s): Lynn D Kramer, MD, Study Chair, Affiliation: Par Pharmaceutical, Inc. John N Mehanna, MD, Principal Investigator, Affiliation: Western Maryland Health System M.Daud Nawabi, MD, Principal Investigator, Affiliation: Lowcountry Hematology & Oncology, PA Marc A Saltzman, MD, Principal Investigator, Affiliation: Innovative Medical Research of South Florida, Inc
Summary
Purpose of the study is to compare the effects of megestrol acetate concentrated suspension
and placebo for the treatment of cancer-associated anorexia in patients with lung or
pancreatic cancer
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Caloric intake
Secondary outcome: Body compositionWeight Patient reported appetite
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Innovative Medical Research of South Florida, Inc, Miami, Florida 33179, United States
Western Maryland Health System, Cumberland, Maryland 21502, United States
Lowcountry Hematology & Oncology, PA, Mt. Pleasant, South Carolina 29464, United States
Additional Information
Starting date: June 2006
Last updated: March 11, 2008
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