Breast Cancer Clinical Trial
Official title:
Pilot Study Evaluating Aprepitant (MK-869) for Prevention of Nausea & Vomiting Secondary to High Dose Cyclophosphamide Administered to Patients Underging Undergoing Peripheral Hematopoietic Progenitor Cell Mobilization Prior to Autologous Transplantation
RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help
lessen or prevent nausea and vomiting in patients treated with chemotherapy.
PURPOSE: This clinical trial is studying how well giving aprepitant together with
granisetron and dexamethasone works in preventing nausea and vomiting in patients receiving
cyclophosphamide before undergoing an autologous stem cell transplant.
OBJECTIVES:
Primary
- Evaluate the efficacy of the addition of aprepitant in controlling acute vomiting with
the standard prophylactic anti-emetic combination of granisetron hydrochloride and
dexamethasone in patients receiving therapy comprising high-dose cyclophosphamide to
mobilize stem cells prior to leukapheresis for autologous stem cell transplantation.
Secondary
- Evaluate the efficacy of the addition of aprepitant in controlling delayed vomiting in
these patients.
- Evaluate the efficacy of the addition of aprepitant in controlling overall nausea in
these patients.
- Identify side effects of the addition of aprepitant to this regimen in these patients.
OUTLINE: Patients receive granisetron hydrochloride orally or IV and oral dexamethasone,
followed 1 hour later by cyclophosphamide IV over 2 hours on day 1. Patients also receive
oral aprepitant once daily on days 1-3. Treatment continues in absence of unacceptable
toxicity.
After completion of study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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