Status:
COMPLETED
Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Lymphoma Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical research study is to learn the effect of combining aprepitant with CHOP or R-CHOP in patients with Non-Hodgkin's Lymphoma (NHL) that is either newly diagnosed or has come bac...
Detailed Description
The Study Drugs: Aprepitant is designed to block the natural substance in the brain that causes nausea and vomiting. This may help to prevent and/or control nausea and vomiting caused by cancer chemo...
Eligibility Criteria
Inclusion
- Newly diagnosed or relapsed lymphoid malignancy.
- Patients receiving either:(1) Bolus or 48-hr infusion CHOP (cyclophosphamide 750 mg/m\^2 IV Day 1, doxorubicin 25 mg/m\^2/day IV given as bolus infusion or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg \* 5 days) OR (2) Bolus or 48-hr infusion R-CHOP (Rituximab 375mg/m\^2 on Day 1+ CHOP as above). (For patients receiving R-CHOP, CHOP may be administered starting on Day 2 at the discretion of the treating physician
- Age \>/= to 18 years
- Adequate organ function defined as serum total bilirubin \</= 1.2 mg/dL, serum aspartate aminotransferase or serum glutamate oxaloacetate transaminase (SGOT) \</= 60 IU/L, creatinine \< 1.5 mg/dL.
Exclusion
- Evidence of neoplastic central nervous system disease
- Patients who are unable to take oral medication (e.g. due to tumor obstruction)
- History of Diabetes Mellitus (Diabetes as defined by established diagnosis of diabetes currently receiving medications for the diabetes management and/or a fasting blood glucose of \>/= 126 mg/dL.)
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00651755
Start Date
March 1 2008
End Date
September 1 2011
Last Update
July 2 2013
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030