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

NCT00637728 | Terminated Phase 3 Results

• 1 other identifier: 100.2.C.006 TRANSFERRED
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Anorexia; Cachexia; Weight Loss

Keywords

Megestrol acetate; Anorexia; Cachexia; Lung cancer; Pancreatic cancer; Unintended weight loss; Body weight; Appetite; Megace ES

Outcome Measures

Primary Outcomes (1)

• Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase

  The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week's daily caloric intake value.

  8 weeks

Secondary Outcomes (3)

• Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline

  Baseline, Week 4 and Week 8

• Change in Weight Over the Course of the 8-week Double-blind Phase

  Baseline, Week 1, 2, 3, 4, 6, and 8

• Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale

  Baseline, Weeks 1, 2, 3, 4, 6 and 8

Study Arms (2)

1

ACTIVE COMPARATOR

Megestrol acetate concentrated suspension 110 mg/mL

Drug: Megestrol acetate concentrated suspension 110 mg/mL

2

PLACEBO COMPARATOR

Placebo suspension

Drug: Placebo

Interventions

Megestrol acetate concentrated suspension 110 mg/mL DRUG

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

Also known as: Megace ES

1

Placebo DRUG

Placebo oral suspension, 5 mL once daily

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• PRA Health Sciences: collaborator

Study Sites (3)

Innovative Medical Research of South Florida, Inc

Miami, Florida, 33179, United States

Location

Western Maryland Health System

Cumberland, Maryland, 21502, United States

Location

Lowcountry Hematology & Oncology, PA

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Anorexia; Cachexia; Weight Loss; Lung Neoplasms; Pancreatic Neoplasms; Body Weight

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Thinness; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: M. Todd Kirby, PhD
• Organization: Endo Pharmaceuticals Inc.

kirby.todd@endo.com

(484) 216-6491

Study Officials

• Lynn D Kramer, MD

  Par Pharmaceutical, Inc.

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 18, 2008
• Study Start: June 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: June 23, 2016
• Results First Posted: February 29, 2016

Record last verified: 2016-05

Locations

US (3)