Phase I Dose-Finding Pilot Study of the Safety and Tolerability of Olanzapine in Patients With Advanced Cancer and Weight Loss
Olanzapine is approved for the treatment of schizophrenia and bipolar disorder. However,
patients who have received this drug for these reasons have also experienced weight gain.
Further studies in patients with cancer showed an improvement in appetite, a decrease in
nausea, and a control of flushing (feeling of warmth) and sweating.
If you are found to be eligible to take part in this study and before you receive your first
dose of Olanzapine, you will have routine blood tests (about 2 teaspoons). You will be asked
a series of questions about your nutrition and how well you are able to perform daily
activities. These questions should take about 20 minutes to answer. Your answers will help
the study doctor decide if the study drug is helping you gain weight and if your weight gain
is helping you feel better. You will also have an electrocardiogram (ECG - a test to measure
the electrical activity of the heart). Women who are able to have children must have a
negative blood pregnancy test (about 1 teaspoon).
After the tests above are completed, you will begin receiving Olanzapine. The study drug
will be taken by mouth once daily at bedtime for 28 days in a row. Seven different doses of
the drug are planned with 6 patients enrolled on each level. The level you are assigned to
will depend on when you are enrolled on this study. All participants will begin taking the
same strength of the study drug. This will gradually increase about every 3 - 14 days until
you reach the highest strength of the study drug for the dose level to which you are
About every 2 weeks during this study for the first month and then about once a month
thereafter, you will have a physical exam, including measurement of your vital signs (blood
pressure, heart rate, temperature, and breathing rate), and your medical history will be
discussed. You will also have routine blood tests (about 2 teaspoons) to check your general
You will continue to receive the highest strength of the study drug for the dose level to
which you are assigned for about 4 months unless you have intolerable side effects or if
your weight continues to decrease. The study doctor will decide if you should continue
receiving Olanzapine after 4 months.
This is an investigational study. The FDA has approved Olanzapine for mental health
diseases (schizophrenia, acute mania, and bipolar disorder). Its use in preventing weight
loss is experimental. Up to 57 patients will take part in this study. All will be enrolled
at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
Toxicity evaluation after one 28-day cycle (& each dose level).
Aung Naing, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|