Breast Cancer Clinical Trial
Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant
Summary
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.
Full Description
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Undergoing autologous peripheral blood stem cell transplantation and stem cell mobilization using cyclophosphamide
Candidate (per institutional requirements) for autologous peripheral blood stem cell transplantation
No psychiatric illness or multi-system organ failure
No nausea at baseline
PATIENT CHARACTERISTICS:
SWOG performance status 0-2
Fewer than 5 alcoholic drinks per day within the past year
No current illness requiring chronic systemic steroids or requirement for chronic use of anti-emetics
No gastrointestinal obstruction or active peptic ulcer disease
AST and ALT ≤ 3 times upper limit of normal (ULN)
Bilirubin ≤ 3 times ULN
Alkaline phosphatase ≤ 3 times ULN
Creatinine ≤ 2 mg/dL
No known hypersensitivity to any component of the study regimen
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception
No unrelenting hiccups
PRIOR CONCURRENT THERAPY:
No chronic therapeutic warfarin > 1 mg dose per day
No other concurrent investigational agents
No concurrent oral contraceptives (except for stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine hydrochloride, or diltiazem hydrochloride
No concurrent illegal drugs
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There is 1 Location for this study
Detroit Michigan, 48201, United States
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