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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00651755
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aprepitant — DRUG
    125 mg By Mouth (PO) On Day 1, followed by 80 mg PO Daily On Days 2-3.
  • Cyclophosphamide — DRUG
    750 mg/m\^2 By Vein On Day 1
  • Doxorubicin — DRUG
    25 mg/m\^2 By Vein Over 48 Hours On Days 1-2
  • Vincristine — DRUG
    2 mg By Vein On Day 1
  • Prednisone — DRUG
    100 mg PO for 5 Days
  • Rituximab — DRUG
    375 mg/m\^2 By Vein On Day 1.
  • Ondansetron — DRUG
    8 mg daily for 2 days

Study Details

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 Dates

Start date
Mar 31, 2008
Status verified
Jun 2013
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Aprepitant + CHOP/R-CHOP
    Aprepitant 125 mg oral (PO) Day 1 of Cycle 1 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m\^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP \[cyclophosphamide 750 mg/m\^2 IV Day 1, doxorubicin 25 mg/m\^2/day IV given bolus or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg \* 5 days\]; or (2) Bolus or 48-hour infusion R-CHOP \[Rituximab 375 mg/m\^2 on Day 1 + CHOP as above\]. \[For patients receiving R-CHOP, CHOP may be administered starting on Day 2 at the discretion of the treating physician\]
  • Experimental: Standard of Care (Control) + CHOP/R-CHOP
    Anti-emetics, Ondansetron 8 mg daily for 2 days, plus steroids in CHOP or R-CHOP regimen.

Primary Outcome Measure

Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group [ Time Frame: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

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By research site
UT MD Anderson Cancer Center· Houston, TX

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