An Investigational Drug for the Prevention of Chemotherapy-Induced Nausea and Vomiting - Full Text View

Purpose

This protocol will study an investigational drug treatment plan against standard therapy in the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic chemotherapy.

Condition	Intervention	Phase
Nausea Vomiting Breast Neoplasms	Drug: MK0869, aprepitant / Duration of Treatment: 3 days Drug: Comparator: ondansetron / Duration of Treatment: 3 days	Phase IV

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer Nausea and Vomiting

ChemIDplus related topics:

Ondansetron Ondansetron hydrochloride Aprepitant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy

Further study details as provided by Merck:

Primary Outcome Measures:

Emesis and use of rescue medication
Safety and tolerability

Secondary Outcome Measures:

Quality of life

Estimated Enrollment:	820
Study Start Date:	December 2002

Eligibility

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

Criteria

Inclusion Criteria:

Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.

Exclusion Criteria:

Patient has a central nervous system malignancy.
Patient will receive radiation to the abdomen or pelvis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092183

Locations


United States, Pennsylvania
	Call for Information
	Horsham, Pennsylvania, United States, 19044

Sponsors and Collaborators

Merck

More Information

Publications:

Warr DG, Hesketh PJ, Gralla RJ, Muss HB, Herrstedt J, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Bohidar N, Klinger G, Hustad CM, Horgan KJ, Skobieranda F. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol. 2005 Apr 20;23(12):2822-30.

Study ID Numbers:	2004_063
First Received:	September 21, 2004
Last Updated:	June 2, 2006
ClinicalTrials.gov Identifier:	NCT00092183
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Chemotherapy-Induced Nausea and Vomiting

Study placed in the following topic categories:

Signs and Symptoms

Vomiting

Signs and Symptoms, Digestive

Skin Diseases

Breast Neoplasms

Nausea

Ondansetron

Serotonin

Breast Diseases

Aprepitant

Additional relevant MeSH terms:

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Gastrointestinal Agents

Central Nervous System Depressants

Antiemetics

Antipsychotic Agents

Pharmacologic Actions

Neoplasms

Serotonin Antagonists

Serotonin Agents

Neoplasms by Site

Autonomic Agents

Therapeutic Uses

Antipruritics

Anti-Anxiety Agents

Peripheral Nervous System Agents

Central Nervous System Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on October 09, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092183