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.
Status | Completed |
Enrollment | 40 |
Est. completion date | February 2012 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Barbara Ann Karmanos Cancer Institute | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Overall Nausea Controlled | at 0-120 hours | Yes | |
Primary | Proportion of Participants With Controlled Acute Vomiting | No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration. | at 0-24 hours | Yes |
Secondary | Delayed Vomiting Controlled | at 25-120 hours | Yes | |
Secondary | Toxicity Grade 3, 4, or 5 | at 0-120 hours | Yes |
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