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

This study has been terminated.
(Difficulty finding the required patient population)
Sponsor:
Collaborator:
PRA International
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00637728
First received: March 11, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on July 31, 2014