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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 composition

Weight

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

Page last updated: August 23, 2015

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