Overview

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

Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Aprepitant
Cyclophosphamide
Doxorubicin
Fosaprepitant
Liposomal doxorubicin
Ondansetron
Prednisone
Rituximab
Vincristine
Criteria
Inclusion Criteria:

1. Newly diagnosed or relapsed lymphoid malignancy.

2. 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

3. Age >/= to 18 years

4. Adequate organ function defined as serum total bilirubin aspartate aminotransferase or serum glutamate oxaloacetate transaminase (SGOT) IU/L, creatinine < 1.5 mg/dL.

Exclusion Criteria:

1. Evidence of neoplastic central nervous system disease

2. Patients who are unable to take oral medication (e.g. due to tumor obstruction)

3. 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.)