Oral Neurokinin-1 Antagonist, Aprepitant, in Combination With Ondansetron and Dexamethasone in Patients Undergoing Autologous Peripheral Blood Stem Cell Transplantation - Full Text View

Sponsors and Collaborators:	Washington University School of Medicine Merck
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00285272

Purpose

The purpose of this study is to determine if the use of aprepitant in patients undergoing bone marrow transplants will lead to a reduction in symptoms of nausea and vomiting.

Condition	Intervention	Phase
Chemotherapy Induced Nausea and Vomiting Non-Hodgkins Lymphoma Multiple Myeloma	Drug: aprepitant	Phase IV

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Lymphoma Multiple Myeloma Nausea and Vomiting

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Ondansetron Ondansetron hydrochloride Aprepitant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Study Evaluating the Efficacy and Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combination With Ondansetron and Dexamethasone in Patients Undergoing Autologous Peripheral Blood Stem Cell Transplantation

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

nausea/vomiting as defined below
Emetic control will be defined by the number of emetic episodes (see definitions) occurring within a 24-hour period, or the requirement for rescue medication. Emetic control will be defined as follows:
Complete: no episodes of emesis or nausea in any 24-hour period after administration of study antiemetics, with no rescue antiemetics needed.
Major: One or two episodes of nausea or vomiting, or the need for antiemetic rescue medication.
Minor: Three to five episodes of nausea or vomiting.
Treatment failure: More than five emetic episodes
Emetic episodes will be defined as single vomit or retch, or any number of continuous vomits or retches; distinct episodes must be separated by at least one minute.
Nausea61: A subjective, unobservable phenomenon of an unpleasant sensation in the back of the throat and the epigastrium that may or may not culminate in vomiting.
Vomiting61: The forceful expulsion of the contents of the stomach, duodenum or jejunum through the oral cavity.
Retching61: The unsuccessful attempt to vomit without expelling gastrointestinal contents.
Acute phase62: The first 24 hours after initiation of chemotherapy.
Delayed phase62: Nausea and vomiting occurring 24 hours after initiation of chemotherapy administration. It may begin as early as 16 hours after chemotherapy administration.
Anticipatory CINV62: Nausea and vomiting occurring as a result of a conditioned response from previous chemotherapy treatment.
Breakthrough CINV62: Nausea and vomiting occurring despite preventive therapy.
Refractory CINV62: Nausea and vomiting occurring during subsequent cycles of chemotherapy when antiemetic prophylaxis or rescue therapy (or both) has failed in earlier cycles
Objective Measurements
7.3.1.1 Proportion of patients with or without emesis in the acute and delayed phase
7.3.1.2. Number, time to onset, and duration of emetic episodes after chemotherapy administration
7.3.1.3 Need for breakthrough antiemetics

Secondary Outcome Measures:

pharmacokinetic parameters as well as Patient Treatment Diary
• Daily while hospitalized, beginning on day 1 of transplant conditioning regimen until count recovery (ANC > 1500 x 2 days) and then weekly until day +30.
• Once discharged, weekly until day + 30 post transplant
• Nausea will be assessed every 24 hours in the patient diary using a 100-mm horizontal visual analog scale
• Patient's number of emetic episodes will be documented
• Record of oral fluid intake
• Quality of life questions pertaining to nausea and vomiting will be assessed
7.3.3 Toxicity Assessment (see Appendix C)
7.3.3.1 Toxicity of the antiemetic regimens will be assessed every 24 hours until count recovery (ANC >1500 x 2 days) and then weekly until day +30.
7.3.3.1.1 Side effects associated with the antiemetics
7.3.3.1.2 Creatinine daily until count recovery (ANC >1500 x 2 days) and then weekly until day +30
7.3.3.1.3 Liver function tests including total bilirubin, AST, ALT, and alkaline phosphatase at least twice weekly until count recovery (ANC >1500 x 2 days) and then weekly until day +30

Estimated Enrollment:	100
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2008

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

Male or female patients 18 years of age or older
Patients deemed eligible to undergo autologous bone marrow or peripheral stem cell transplant therapy per usual transplant inclusion and exclusion criteria
Patients with Non-Hodgkins Lymphoma or Multiple Myeloma
Written informed consent

Exclusion Criteria:

Nausea at baseline
Chronic use of other antiemetic agent(s)
Gastrointestinal obstruction or active peptic ulcer
Radiation therapy to pelvis or abdomen within 1 week before or after study day 1
Allogeneic stem cell transplant recipient
AST > 3x ULN
ALT > 3x ULN
Bili > 3x ULN
Alk Phos > 3x ULN
Creatinine >2
Known hypersensitivity to any component of study regimen
Pregnant or lactating women
Participating in a clinical trial which involves other investigational agent(s)
Patients taking any of the following medications: warfarin, oral contraceptives (except for the administration of stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine, and/or diltiazem.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285272

Contacts

Contact: Kristan Augustin, Pharm.D.

314-454-8512

kma3852@bjc.org

Locations

United States, Missouri
Barnes-Jewish Hosptial/ Siteman Cancer Center/ Washington University	Recruiting
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Merck

Investigators

Study Chair:

John DiPersio, MD,PhD

Washington University School of Medicine

More Information

Study ID Numbers:	hsc 031192, ind 70268
Study First Received:	January 31, 2006
Last Updated:	October 25, 2007
ClinicalTrials.gov Identifier:	NCT00285272
Health Authority:	United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:

Chemotherapy induced nausea and vomiting
aprepitant
neurokinin antagonist

Human stem cell transplant
Non-Hodgkins Lymphoma
Multiple myeloma

Study placed in the following topic categories:

Dexamethasone
Vomiting
Signs and Symptoms, Digestive
Blood Protein Disorders
Lymphoma, small cleaved-cell, diffuse
Paraproteinemias
Hemostatic Disorders
Signs and Symptoms
Hemorrhagic Disorders
Multiple myeloma
Nausea
Ondansetron
Lymphoma

Dexamethasone acetate
Aprepitant
Immunoproliferative Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Serotonin
Substance P
Multiple Myeloma
Lymphatic Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Serotonin Antagonists
Therapeutic Uses
Antipruritics
Cardiovascular Diseases
Dermatologic Agents
Tranquilizing Agents

Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Glucocorticoids
Pharmacologic Actions
Neoplasms
Serotonin Agents
Autonomic Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009