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

Par Pharmaceutical

Status and phase

Terminated

Phase 3

Conditions

Weight Loss

Anorexia

Cachexia

Treatments

Drug: Megestrol acetate concentrated suspension 110 mg/mL

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00637728

100.2.C.006 TRANSFERRED

Details and patient eligibility

About

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

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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