Status:
COMPLETED
Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Chronic Myeloproliferative Disorders
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief 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 ...
Detailed 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 dexame...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00293384
Start Date
October 1 2004
End Date
February 1 2012
Last Update
March 15 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379