Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Not Enrolling
Both
Anorexia, Cachexia, Weight Loss

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Caloric intake

Outcome Time Frame:

Daily

Safety Issue:

No

Principal Investigator

Lynn D Kramer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Par Pharmaceutical, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

100.2.C.006

NCT ID:

NCT00637728

Start Date:

June 2006

Completion Date:

September 2006

Related Keywords:

  • Anorexia
  • Cachexia
  • Weight Loss
  • Megestrol acetate
  • Anorexia
  • Cachexia
  • Lung cancer
  • Pancreatic cancer
  • Unintended weight loss
  • Body weight
  • Appetite
  • Megace ES
  • Anorexia
  • Cachexia
  • Pancreatic Neoplasms
  • Weight Loss

Name

Location

Western Maryland Health SystemCumberland, Maryland  21502
Lowcountry Hematology & Oncology, PaMt. Pleasant, South Carolina  29464
Innovative Medical Research of South Florida, IncNorth Miami Beach, Florida  33179