Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer - Full Text View

Sponsor:	Vanderbilt-Ingram Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00499668

Purpose

RATIONALE: Antiemetic drugs, such as aprepitant and ondansetron, may help lessen nausea and vomiting caused by opioids. It is not yet known whether aprepitant is more effective than ondansetron in treating nausea and vomiting caused by opioids in patients with cancer.

PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works compared to ondansetron in treating nausea and vomiting caused by opioids in patients with cancer.

Condition	Intervention
Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific	Drug: aprepitant Drug: ondansetron hydrochloride

Study Type:	Interventional
Study Design:	Supportive Care, Randomized
Official Title:	A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron Aprepitant

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Control of nausea and vomiting

Secondary Outcome Measures:

Quality of life
Pain control
Mood
Global satisfaction

Estimated Enrollment:	60
Study Start Date:	August 2007
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To evaluate the efficacy of aprepitant as monotherapy for opioid-induced nausea and vomiting (OINV) in comparison to ondansetron hydrochloride in patients who have failed at least one prior anti-emetic agent/regimen.

Secondary

To determine whether control of OINV improves quality of life.
To determine if control in OINV decreases pain.
To determine if control in OINV improves mood.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm A: Patients receive aprepitant orally once daily for 7 days in the absence of unacceptable toxicity or persistent grade 4 nausea and vomiting.
Arm B: Patients receive ondansetron hydrochloride orally 3 times daily for 7 days in the absence of unacceptable toxicity or persistent grade 4 nausea and vomiting.

Patients complete the following questionnaires: Functional Assessment of Cancer Therapy-General (FACT-G); Center for Epidemiologic Studies Depression Scale (CES-D); and Brief Pain Index (BPI) at baseline and on day 7. Patients also complete symptom diaries documenting the following: number of episodes (an emetic episode is defined as a simple vomit or retch, or any number of continuous vomits or retches; distinct episodes that are separated by at least 1 minute) of vomiting or retching including the date and time; worst and average degree of nausea (recorded every 2 hours while awake during the first 24 hours after treatment and every 8 hours on days 1-7); and adverse events other than episodes of vomiting and nausea.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

History of malignancy (including hematological malignancies)
Has pain requiring opioid analgesics
Nausea and vomiting (associated with opioid analgesic use) that is unrelieved by at least one standard antiemetic regimen (including 5HT3 antagonist and dexamethasone combination therapy)
- Patients who have failed ondansetron hydrochloride for treatment of opioid-induced nausea and vomiting will be excluded from the study

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Able to assess severity of nausea and vomiting and document it in the diary
Women must not be pregnant or lactating
Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
Urine pregnancy test will be given to women of childbearing age
No concerns about compliance with medication regimen or medical follow-up (patient must be able to tolerate oral dosing)
No severe or chronic illness or other causes of nausea and vomiting, that in judgment of the treating physician, will place patient at risk
No severe gastrointestinal obstruction or active peptic ulcer disease
Serum ALT and AST < 2 times upper limit of normal (ULN)
Serum bilirubin < 2 times ULN
Serum alkaline phosphatase < 2 times ULN

PRIOR CONCURRENT THERAPY:

No surgery within the past 7 days
No chemotherapy within the past 7 days
No total or lower body radiation therapy within the past 7 days
Patient may not be scheduled to undergo total body irradiation or lower body irradiation, chemotherapy, or surgery during study participation
Patient must not be taking warfarin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499668

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Barbara A. Murphy, MD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000558419, VU-VICC-SUPP-0513, VU-VICC-IRB-070193, MERCK-VU-VICC-SUPP-0513
Study First Received:	July 10, 2007
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00499668 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific
nausea and vomiting
chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis
chronic neutrophilic leukemia
essential thrombocythemia
polycythemia vera
adult acute lymphoblastic leukemia
adult acute myeloid leukemia
acute undifferentiated leukemia
mast cell leukemia
adult T-cell leukemia/lymphoma
T-cell large granular lymphocyte leukemia
chronic lymphocytic leukemia

hairy cell leukemia
prolymphocytic leukemia
AIDS-related lymphoma
adult Hodgkin lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
cutaneous B-cell non-Hodgkin lymphoma
cutaneous T-cell non-Hodgkin lymphoma
mycosis fungoides/Sezary syndrome
adult grade III lymphomatoid granulomatosis
adult nasal type extranodal NK/T-cell lymphoma
Waldenstrom macroglobulinemia
adult Burkitt lymphoma
adult diffuse large cell lymphoma
adult diffuse mixed cell lymphoma

Additional relevant MeSH terms:

Neurotransmitter Agents
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antiemetics
Preleukemia
Serotonin Antagonists
Pathologic Processes
Hemorrhagic Disorders
Therapeutic Uses
Antipruritics
Cardiovascular Diseases
Dermatologic Agents
Aprepitant
Immunoproliferative Disorders

Tranquilizing Agents
Immune System Diseases
Hematologic Diseases
Myeloproliferative Disorders
Antipsychotic Agents
Multiple Myeloma
Neoplasms
Anti-Anxiety Agents
Vomiting
Precancerous Conditions
Blood Protein Disorders
Psychotropic Drugs
Paraproteinemias
Hemostatic Disorders
Leukemia

ClinicalTrials.gov processed this record on February 08, 2010