Return to List

Study Summary
No. 2005-0620:.......Advanced Cancers; Other Supportive; Pediatrics; Phase I Studies......Aung Naing......Investigational Cancer Therapeutics
.
Study Summary Title
Study Summary
Number:
2005-0620
Study Title:Phase I Dose-Finding Pilot Study of the Safety and Tolerability of Olanzapine in Patients with Advanced Cancer and Weight Loss
.
Physician New Patient Referral
Name:Aung NaingPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Investigational Cancer TherapeuticsReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-1930
Contact us about clinical trials
.
General Information
Disease Group:Advanced Cancers
Other Supportive
Pediatrics
Phase I Studies
Supported By:N/A
Phase of Study:Phase IReturn
Visit:
On average every two weeks
Treatment
Agents:
ZyprexaHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
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.
.
Study Objectives / Outcomes
1.1. Primary:
1. The primary objective is to define the safety and maximum tolerated dose (MTD) of Olanzapine in patients with weight loss and cachexia secondary to advanced cancer.

1.2. Secondary:
1. To perform a preliminary assessment of the metabolic profile changes in patients with advanced cancer treated at different doses of Olanzapine.
2. To outline the nutritional status and performance status changes of patients treated at different doses of Olanzapine.
.
Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:07/19/2006
Study Type:Phase I
Recruitment Status:Open
Projected Accrual:N/A
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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, resperidone, olanzapine, quetiapine, ziprasidone or aribpriprazole

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.

.
Links
Registration Number: NCT00489593
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
.
Results


Return to Clinical Trials at M.D. Anderson Cancer Center