Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Lymphoma Patients
NCT00651755 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2013-07-02
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.
Conditions
Interventions
- DRUG
-
Aprepitant
125 mg By Mouth (PO) On Day 1, followed by 80 mg PO Daily On Days 2-3.
- DRUG
-
750 mg/m\^2 By Vein On Day 1
- DRUG
-
Doxorubicin
25 mg/m\^2 By Vein Over 48 Hours On Days 1-2
- DRUG
-
Vincristine
2 mg By Vein On Day 1
- DRUG
-
100 mg PO for 5 Days
- DRUG
-
375 mg/m\^2 By Vein On Day 1.
- DRUG
-
Ondansetron
8 mg daily for 2 days
Sponsors & Collaborators
- collaborator INDUSTRY
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Saroj Vadhan-Raj, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-03-31
- Primary Completion
- 2011-09-30
- Completion
- 2011-09-30
Countries
- United States
Study Locations
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