NCT00489593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 8, 2015

Status Verified

January 1, 2015

Enrollment Period

7.2 years

First QC Date

June 20, 2007

Last Update Submit

January 7, 2015

Conditions

Advanced CancerWeight Loss

Keywords

Advanced CancerWeight LossCachexiaOlanzapineZyprexaFluoxetineSymbyax

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    Toxicity evaluation after one 28-day cycle (& each dose level).

Study Arms (1)

Olanzapine

EXPERIMENTAL

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.

Drug: Olanzapine

Interventions

OlanzapineDRUG

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.

Also known as: Zyprexa, Fluoxetine, Symbyax
Olanzapine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Weight LossCachexia

Interventions

OlanzapineFluoxetineolanzapine-fluoxetine combination

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPropylaminesAminesOrganic Chemicals

Study Officials

  • Aung Naing, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 21, 2007

Study Start

October 1, 2006

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 8, 2015

Record last verified: 2015-01

Locations

US(1)