Trial Information

Preliminary Study to Explore the Effects of Mirtazapine on Appetite in Advanced Cancer Patients

Mirtazapine is a drug that is used to treat clinical depression. It is designed to cause
hormones ("chemical messengers" such as norepinephrine and serotonin) to be released in the
brain, while blocking certain molecules that cause nausea, nervousness, headache, insomnia,
diarrhea, and lowered sex drive. The release of these hormones may provide proper hormonal
balance in the brain, which may increase appetite and weight.

Before you can start treatment on this study, you will have "screening tests." These tests
will help the study doctor decide if you are eligible to take part in this study. You will
have a physical exam, including measurement of your vital signs (blood pressure, heart rate,
temperature, and breathing rate). You will be asked to complete 5 questionnaires that will
ask about your diagnosis, the medication you are taking, how you have been feeling (such as
tense or "wound up"), and any symptoms you may be having (such as pain, poor appetite,
weight loss, fatigue, nausea, sleep problems, and depression), and times you have usually
gone to bed during the past month. In total, these questionnaires will take about 40 minutes
to complete. Women who are able to have children must have a negative urine pregnancy test.

If you are not found to be eligible to take part in this study, you will be provided with a
referral to a palliative care doctor who will check your symptoms and plan the appropriate
treatment.

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to 1 of 2 groups. You will have an equal chance of being in 1 of
the 2 groups. Neither you nor your doctor will know which treatment group you are assigned
to. However, in the event of an emergency, for your safety your doctor will be informed
about what treatment you are receiving.

Participants in one group will take a specified dose of mirtazapine (with or without food)
at bedtime on Days 1-15. On Day 15, you will return to the clinic to repeat the same tests
that you had during the screening visit and to be checked for any side effects you may have
experienced. You will get 2 more prescriptions (2 different doses--a lesser dose and a
greater dose) for mirtazapine. You will then take a lesser dose of mirtazapine (with or
without food) for 7 days. During Week 3, you will take the greater dose of mirtazapine for
another 7 days until Day 29.

Participants in the other group will take a placebo (a substance that looks like the study
drug but has no active ingredients) for 2 weeks. On Day 15, you will return to the clinic
to repeat the same tests that you had during the screening visit and to be checked for any
side effects you may have experienced. You will be given 2 prescriptions (2 different
doses--a lesser dose and a greater dose) for mirtazapine. You will then take a lesser dose
of mirtazapine (with or without food) for a 7 days. During Week 3, you will take the
greater dose of mirtazapine for another 7 days until Day 29.

You will continue taking part in this study until Day 29, unless the disease gets worse or
you experience any intolerable side effects. Otherwise, your participation will end on Day
29, and you will have an end-of-study visit at that time.

Your right arm muscle diameter, your skin fold thickness below your shoulder blade, on the
front and back of your right arm, above your right hip bone, and on the front of your right
thigh will be measured using a skinfold caliper. The caliper is a device used on the
outside of your body to measure skin thickness. You will also be asked to stand on a
special scale that will send an extremely low energy, high frequency electrical signal from
one foot to your other foot. You will not be able to feel this at all. The device uses the
speed at which the signal travels through your body's tissues to calculate body fat weight
and body fat percentage. These numbers are used together to determine your body fat, lean
body weight, and water content of your body. This will be done on Days 1, 15, and 29.

Participants in both groups will be asked to keep 3 weekly diaries: a food diary, a pill
diary recording when mirtazapine is taken, and a daily log of any symptoms that may have
been experienced from the cancer before and after treatment began on this study. You will be
asked to return to the outpatient clinic at the end of 2 weeks (Day 15) when all tests that
were performed during the screening visit will be repeated. All 3 diaries will be reviewed
by the research nurse during this clinic visit.

The study nurse will call you on the phone on Days 2 and 16 to find out if you have had
increased drowsiness or sleepiness (since the beginning of this study). You will also be
called on Days 8 and 22 by the study nurse to check your symptoms, difficulty sleeping, and
other side effects you may be experiencing. The phone calls should last about 5-10 minutes
each time.

For your end-of-study visit (Day 29), you will return to the outpatient Palliative Care and
Rehabilitation Medicine Clinic at M. D. Anderson to be checked on. You will have all of the
same tests that you had during the screening visit as well as a review of any side effects
you may be experiencing. You will repeat the questionnaires, which should take about 40
minutes to complete. You will need to bring your food diary, pill diary, and symptom log
diary to this visit.

All of the study visits will occur on the day listed in this form, or within 3 days earlier
or later.

This is an investigational study. Mirtazapine is approved by the FDA (only at the dose
levels that will be provided in this study) for depression and commercially available. Its
use in this study is experimental. Up to 98 patients will take part in this study. All
will be enrolled at M. D. Anderson.