Phase I Dose-Finding Pilot Study of the Safety and Tolerability of Olanzapine in Patients With Advanced Cancer and Weight Loss
N/A
N/A
Both
Advanced Cancer, Weight Loss
Trial Information
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
assigned.
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
health.
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.
Inclusion Criteria:
1. Patient with confirmed advanced cancer.
2. Patients with decreased daily caloric intake (<1500 Calories/day), or with a weight
loss equivalent to 10% of body weight over six months
3. Patients should be able to have an oral intake and not be dependant on tube feeding,
or have significant oropharyngeal obstruction, gastro-duodenal obstruction, or oral
mucosal inflammation interfering with oral intake. Patients who have undergone
gastro-jejunal bypass, esophagectomy, or total gastrectomy will be excluded.
4. ECOG performance status 2 or less.
5. Normal organ function: Creatinine less or equal to 2 times ULN; Bilirubin less or
equal 2.5 times ULN
6. Ability to understand and the willingness to sign written informed consent.
7. Patients receiving concurrent chemotherapy or radiation therapy are eligible for
enrollment.
8. Expected life expectancy of at least 3 months.
Exclusion Criteria:
1. Uncontrolled concurrent illness such as unstable angina, myocardial infarction in the
preceding month, neutropenic fever, shock, symptomatic decompensate congestive heart
failure, or congestive Heart Failure of NYHA III or IV, active internal bleeding.
2. Hypersensitivity to olanzapine, or history of dyskinesia or extrapyramidal syndrome
on atypical neuroleptic.
3. Concurrent treatment with any atypical antipsychotic such as clozapine, risperidone,
olanzapine, quetiapine, ziprasidone or aripiprazole
4. History of clozapine-induced agranulocytosis because patients will be at increased
risk for neutropenia with Olanzapine.
5. Major surgery within four weeks of study start day.
6. Uncontrolled diabetes mellitus
7. Uncontrolled seizure disorder (any episode in the previous 4 weeks).
8. Pregnant and Nursing women.
9. Patients may not have started an appetite stimulant such as megace or therapeutic
dose of steroids (superior or equal to an equivalent of 4 mg dexamethasone/day), or
increased the dose of such medication (by more than 50%) in the previous week.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose (MTD)
Outcome Time Frame:
Toxicity evaluation after one 28-day cycle (& each dose level).
Safety Issue:
Yes
Principal Investigator
Aung Naing, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2005-0620
NCT ID:
NCT00489593
Start Date:
October 2006
Completion Date:
Related Keywords:
- Advanced Cancer
- Weight Loss
- Advanced Cancer
- Weight Loss
- Cachexia
- Olanzapine
- Zyprexa
- Fluoxetine
- Symbyax
- Weight Loss
- Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
