Treatment of Cancer-Associated Anorexia Using Megestrol Acetate Concentrated Suspension

This study has been terminated.
(Difficulty finding the required patient population)
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00637806
First received: March 11, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.


Condition Intervention Phase
Anorexia
Cachexia
Weight Loss
Drug: Megestrol acetate concentrated suspension 110 mg/mL
Drug: Megestrol acetate concentrated suspension 60 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 Cancer of Multiple Types

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:
  • Weight [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Patient reported appetite [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Enrollment: 4
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
Active Comparator: 2
Megestrol acetate concentrated suspension 60 mg/mL
Drug: Megestrol acetate concentrated suspension 60 mg/mL
Megestrol acetate concentrated suspension 60 mg/mL given as an oral dose of 300 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase
Other Name: Megace ES
Placebo Comparator: 3 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:

  • Cancer of multiple types in stage II, III, or IV and not a candidate for chemotherapy; but may have been receiving radiation therapy
  • Fair, poor, or very poor appetite
  • Cancer-associated anorexia/cachexia (documented weight loss of 2% over the prior week, or at least 5% within past 30 days, or at least 7.5% over prior 3 months, or at least 10% over prior 6 months)
  • Weight loss perceived to be associated with diminished appetite
  • Eastern Cooperative Oncology Group Performance score of 0, 1, or 2
  • Life expectancy greater than 3 months
  • Alert and mentally competent to complete study assessments
  • 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 tumors that may interfere with food consumption
  • AIDS-related wasting
  • Radiation therapy to head and neck, abdomen, or pelvis within past 6 weeks, or for whom radiation therapy is anticipated during the study such that the result may interfere with food consumption
  • Presence of conditions that interfere with oral intake or ability to swallow
  • Absence of normally functioning gut
  • Known mechanical obstruction of the alimentary or biliary tract, or malabsorption syndrome
  • Intractable or frequent vomiting
  • Clinically significant diarrhea
  • History of thromboembolic events, or on long-term anticoagulation for thromboembolism
  • Uncontrolled diabetes mellitus, or symptomatic hypoadrenalism
  • Poorly controlled hypertension or congestive heart failure
  • Pregnant/lactating females, or planning on becoming pregnant
  • Use of appetite stimulants within past 30 days
  • Use of parenteral nutrition or tube feedings within past 1 week
  • Chronic use of steroids within past 3 months (intermittent short-term use allowed)
  • Current use of illicit substances
  • Allergy, hypersensitivity, or other 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: NCT00637806

Locations
United States, California
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
United States, North Carolina
Four Seasons Hospice and Paliative Care
Flat Rock, North Carolina, United States, 28731
Wake Forest University
High Point, North Carolina, United States, 27262
United States, Ohio
Summit Oncology Associates, Inc.
Akron, Ohio, United States, 44304
Sponsors and Collaborators
Par Pharmaceutical, Inc.
PRA Health Sciences
Investigators
Study Chair: Lynn D Kramer, MD Par Pharmaceutical, Inc.
Principal Investigator: Janet Bull, MD Four Seasons Hospice and Paliative Care
Principal Investigator: Veena Charu, MD Pacific Cancer Medical Center, Inc.
Principal Investigator: Bart Frizzell, MD Wake Forest University, Dept of Radiation Oncology
Principal Investigator: Mehool Patel, MD Summit Oncology Associates, Inc.
  More Information

No publications provided

Responsible Party: VP Clinical & Medical Affairs, Par Pharmaceutical, Inc
ClinicalTrials.gov Identifier: NCT00637806     History of Changes
Other Study ID Numbers: 100.2.C.005
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
Cancer
Unintended weight loss
Body weight
Appetite
Megace ES

Additional relevant MeSH terms:
Anorexia
Cachexia
Weight Loss
Body Weight
Body Weight Changes
Emaciation
Signs and Symptoms
Signs and Symptoms, Digestive
Megestrol
Megestrol Acetate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Appetite Stimulants
Central Nervous System Agents
Central Nervous System Stimulants
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014