Treatment of Cancer-Anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients - Full Text View

Purpose

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

Condition	Intervention	Phase
Anorexia Cachexia Weight Loss	Drug: Megestrol acetate concentrated suspension 110 mg/mL Drug: Placebo	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer Weight Control

Drug Information available for: Megestrol acetate

U.S. FDA Resources

Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:

Caloric intake [ Time Frame: Daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body composition [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
Weight [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Patient reported appetite [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Enrollment:	5
Study Start Date:	June 2006
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Megestrol acetate concentrated suspension 110 mg/mL	Drug: Megestrol acetate concentrated suspension 110 mg/mL Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase Other Name: Megace ES
Placebo Comparator: 2 Placebo suspension	Drug: Placebo Placebo oral suspension, 5 mL once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637728

Locations

United States, Florida
Innovative Medical Research of South Florida, Inc
Miami, Florida, United States, 33179
United States, Maryland
Western Maryland Health System
Cumberland, Maryland, United States, 21502
United States, South Carolina
Lowcountry Hematology & Oncology, PA
Mt. Pleasant, South Carolina, United States, 29464

Sponsors and Collaborators

Par Pharmaceutical, Inc.

PRA International

Investigators

Study Chair:	Lynn D Kramer, MD	Par Pharmaceutical, Inc.
Principal Investigator:	John N Mehanna, MD	Western Maryland Health System
Principal Investigator:	M.Daud Nawabi, MD	Lowcountry Hematology & Oncology, PA
Principal Investigator:	Marc A Saltzman, MD	Innovative Medical Research of South Florida, Inc

More Information

No publications provided

Responsible Party:	VP Clinical & Medical Affairs, Par Pharmaceutical, Inc
ClinicalTrials.gov Identifier:	NCT00637728 History of Changes
Other Study ID Numbers:	100.2.C.006
Study First Received:	March 11, 2008
Last Updated:	March 11, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:

Megestrol acetate
Anorexia
Cachexia
Lung cancer
Pancreatic cancer

Unintended weight loss
Body weight
Appetite
Megace ES

Additional relevant MeSH terms:

Anorexia
Cachexia
Pancreatic Neoplasms
Weight Loss
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Body Weight Changes
Body Weight
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases

Endocrine System Diseases
Megestrol
Megestrol Acetate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Appetite Stimulants
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on May 16, 2013