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

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

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

Drug Information available for: 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
Study 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 January 14, 2009