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15.1
Megace (Megace)
15.11
Preparation and storage: Megace is an orally active derivative
derivative of the naturally occurring
hormone, progesterone. It is supplied as a 40 mg/ml liquid suspension.
Each bottle will contain 600 mL, a 30-day supply. It has a prolonged
half-life suggesting that a once daily dose is appropriate.
It has been extensively utilized in the treatment of hormone
sensitive breast and endometrial cancers. Megace liquid formulation
is stable when stored under normal conditions of room temperature
and humidity.
15.12
Known potential toxicities: Its major "toxicity" being excessive
weight gain. It has been associated with irregular menstrual periods
in women and impotence in men. Sodium retention and worsening
of hypertension may occasionally occur. Megace may cause adrenal
suppression or hyperglycemia.
15.13
Drug procurement: Bristol-Myers will supply the active drug and
an identical-appearing placebo (liquid preparation) to patients
free of charge. Dr. Loprinzi will hold the IND.
To obtain the initial supply of coded bottles, submit by mail
or fax the NCCTG Clinical Drug Order/Return Form request to:
Online Research
First
Street, SW
Rochester, MN 555555
Fax: 555-555-1111
Randomization Center personnel will monitor the supply of coded
bottles at each participating institution and will remind the
participating institution to order drug when needed.
15.2
Marinol
15.21
Preparation and storage: Marinol is supplied in a 2.5 mg soft
capsule. There will be 60 capsules/bottle, a 30-day supply. Store
in a locked refrigerator.
15.22
Known potential toxicities: Effects of Marinol may include: drowsiness,
dizziness, muddled thinking, and brief loss of coordination, sensory
and reasoning functions; easy laughing and "heightened awareness."
Events reported in less than 1% of patients include: ringing in
the ears (tinnitus), nightmares, speech difficulties, facial flushing,
perspiring, a feeling of passing out, diarrhea, inability to control
bowel movements, and muscle pain.
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