Olanzapine in Patients With Advanced Cancer and Weight Loss

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Fluoxetine; Olanzapine

Criteria

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.