An Investigational Drug for the Prevention of Chemotherapy-Induced Nausea and Vomiting (MK-0869-071)
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: December 1, 2003
Interventions
- Drug: MK0869, aprepitant / Duration of Treatment: 3 days
- Drug: Comparator: ondansetron / Duration of Treatment: 3 days
Clinical Trial Outcome Measures
Primary Measures
- Emesis and use of rescue medication
- Safety and tolerability
Secondary Measures
- Quality of life
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Medical Monitor, Study Director, Merck Sharp & Dohme LLC
References
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. doi: 10.1200/JCO.2005.09.050. Erratum In: J Clin Oncol. 2005 Aug 20;23(24):5851. Dosage error in published abstract; MEDLINE/PubMed abstract corrected.
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