Treatment of Cancer-Associated Anorexia Using Megestrol Acetate Concentrated Suspension

Condition(s) targeted: Anorexia; Cachexia; Weight Loss

Intervention: Megestrol acetate concentrated suspension 110 mg/mL (Drug); Megestrol acetate concentrated suspension 60 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.
Janet Bull, MD, Principal Investigator, Affiliation: Four Seasons Hospice and Paliative Care
Veena Charu, MD, Principal Investigator, Affiliation: Pacific Cancer Medical Center, Inc.
Bart Frizzell, MD, Principal Investigator, Affiliation: Wake Forest University, Dept of Radiation Oncology
Mehool Patel, MD, Principal Investigator, Affiliation: Summit Oncology Associates, Inc.

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

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

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:

Weight

Patient reported appetite

Body composition

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Pacific Cancer Medical Center, Inc., Anaheim, California 92801, United States

Four Seasons Hospice and Paliative Care, Flat Rock, North Carolina 28731, United States

Wake Forest University, High Point, North Carolina 27262, United States

Summit Oncology Associates, Inc., Akron, Ohio 44304, United States

Starting date: June 2006
Last updated: March 11, 2008