Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Lymphoma Patients

Completed · Not applicable

Conditions studied: Lymphoma

In brief

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 back. Researchers also want to see if aprepitant can help to prevent nausea and/or vomiting that may be caused by chemotherapy treatment with CHOP or R-CHOP, in these patients. CHOP consists of four drugs - Cyclophosphamide (also called Cytoxan/Neosar), Doxorubicin (or Adriamycin), Vincristine (Oncovin) and Prednisolone while R-CHOP includes Rituximab and CHOP.

Key facts

Study ID

NCT00651755

Run by

M.D. Anderson Cancer Center

People needed

23

Starts

2008-03-01

Expected to finish

2011-09-01

Last updated by the study team

2013-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.)

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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