Olanzapine in Patients With Advanced Cancer and Weight Loss
Primary Purpose
Advanced Cancer, Weight Loss
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Olanzapine
Sponsored by

About this trial
This is an interventional treatment trial for Advanced Cancer focused on measuring Advanced Cancer, Weight Loss, Cachexia, Olanzapine, Zyprexa, Fluoxetine, Symbyax
Eligibility Criteria
Inclusion Criteria:
- Patient with confirmed advanced cancer.
- Patients with decreased daily caloric intake (<1500 Calories/day), or with a weight loss equivalent to 10% of body weight over six months
- 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.
- ECOG performance status 2 or less.
- Normal organ function: Creatinine less or equal to 2 times ULN; Bilirubin less or equal 2.5 times ULN
- Ability to understand and the willingness to sign written informed consent.
- Patients receiving concurrent chemotherapy or radiation therapy are eligible for enrollment.
- Expected life expectancy of at least 3 months.
Exclusion Criteria:
- 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.
- Hypersensitivity to olanzapine, or history of dyskinesia or extrapyramidal syndrome on atypical neuroleptic.
- Concurrent treatment with any atypical antipsychotic such as clozapine, risperidone, olanzapine, quetiapine, ziprasidone or aripiprazole
- History of clozapine-induced agranulocytosis because patients will be at increased risk for neutropenia with Olanzapine.
- Major surgery within four weeks of study start day.
- Uncontrolled diabetes mellitus
- Uncontrolled seizure disorder (any episode in the previous 4 weeks).
- Pregnant and Nursing women.
- 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.
Sites / Locations
- UT MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Olanzapine
Arm Description
Olanzapine 2.5 mg by mouth (PO) Daily x 28 days, increasing about every 3-14 days in increments of 2.5-5 mg until the designated dose for that cohort is reached.
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose (MTD)
Secondary Outcome Measures
Full Information
NCT ID
NCT00489593
First Posted
June 20, 2007
Last Updated
January 7, 2015
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00489593
Brief Title
Olanzapine in Patients With Advanced Cancer and Weight Loss
Official Title
Phase I Dose-Finding Pilot Study of the Safety and Tolerability of Olanzapine in Patients With Advanced Cancer and Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of the drug Olanzapine that can be given to patients with advanced cancer who are experiencing weight loss. Researchers want to find out if Olanzapine can help decrease weight loss in patients who are experiencing it because of cancer. How this drug affects performance status, cancer-related symptoms, and nutritional status in patients with advanced cancer will also be studied.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Weight Loss
Keywords
Advanced Cancer, Weight Loss, Cachexia, Olanzapine, Zyprexa, Fluoxetine, Symbyax
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olanzapine
Arm Type
Experimental
Arm Description
Olanzapine 2.5 mg by mouth (PO) Daily x 28 days, increasing about every 3-14 days in increments of 2.5-5 mg until the designated dose for that cohort is reached.
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa, Fluoxetine, Symbyax
Intervention Description
2.5 mg by mouth (PO) Daily x 28 days, increasing about every 3-14 days in increments of 2.5-5 mg until the designated dose for that cohort is reached.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD)
Time Frame
Toxicity evaluation after one 28-day cycle (& each dose level).
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with confirmed advanced cancer.
Patients with decreased daily caloric intake (<1500 Calories/day), or with a weight loss equivalent to 10% of body weight over six months
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.
ECOG performance status 2 or less.
Normal organ function: Creatinine less or equal to 2 times ULN; Bilirubin less or equal 2.5 times ULN
Ability to understand and the willingness to sign written informed consent.
Patients receiving concurrent chemotherapy or radiation therapy are eligible for enrollment.
Expected life expectancy of at least 3 months.
Exclusion Criteria:
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.
Hypersensitivity to olanzapine, or history of dyskinesia or extrapyramidal syndrome on atypical neuroleptic.
Concurrent treatment with any atypical antipsychotic such as clozapine, risperidone, olanzapine, quetiapine, ziprasidone or aripiprazole
History of clozapine-induced agranulocytosis because patients will be at increased risk for neutropenia with Olanzapine.
Major surgery within four weeks of study start day.
Uncontrolled diabetes mellitus
Uncontrolled seizure disorder (any episode in the previous 4 weeks).
Pregnant and Nursing women.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aung Naing, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center
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Olanzapine in Patients With Advanced Cancer and Weight Loss
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