Evaluation of Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Patients With Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group
研究概览
简要总结
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.
详细描述
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 chemotherapy treatment.
CHOP and R-CHOP are commonly used chemotherapy regimens for treating NHL.
In the blood, aprepitant may increase or decrease the drug levels of cyclophosphamide, vincristine, and/or prednisone (which are part of the CHOP and R-CHOP regimens), but this is not known for certain. This study is designed to help researchers learn the effect of combining aprepitant with CHOP and R-CHOP.
Study Groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.)
研究组 & 干预措施
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]
干预措施: Aprepitant (Drug)
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]
干预措施: Cyclophosphamide (Drug)
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]
干预措施: Doxorubicin (Drug)
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]
干预措施: Vincristine (Drug)
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]
干预措施: Prednisone (Drug)
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]
干预措施: Rituximab (Drug)
Standard of Care (Control) + CHOP/R-CHOP
Anti-emetics, Ondansetron 8 mg daily for 2 days, plus steroids in CHOP or R-CHOP regimen.
干预措施: Cyclophosphamide (Drug)
Standard of Care (Control) + CHOP/R-CHOP
Anti-emetics, Ondansetron 8 mg daily for 2 days, plus steroids in CHOP or R-CHOP regimen.
干预措施: Doxorubicin (Drug)
Standard of Care (Control) + CHOP/R-CHOP
Anti-emetics, Ondansetron 8 mg daily for 2 days, plus steroids in CHOP or R-CHOP regimen.
干预措施: Vincristine (Drug)
Standard of Care (Control) + CHOP/R-CHOP
Anti-emetics, Ondansetron 8 mg daily for 2 days, plus steroids in CHOP or R-CHOP regimen.
干预措施: Prednisone (Drug)
Standard of Care (Control) + CHOP/R-CHOP
Anti-emetics, Ondansetron 8 mg daily for 2 days, plus steroids in CHOP or R-CHOP regimen.
干预措施: Rituximab (Drug)
Standard of Care (Control) + CHOP/R-CHOP
Anti-emetics, Ondansetron 8 mg daily for 2 days, plus steroids in CHOP or R-CHOP regimen.
干预措施: Ondansetron (Drug)
结局指标
主要结局
Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group
时间窗: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of Cyclophosphamide (CP) during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).
Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group
时间窗: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 2-deCI-CP, during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).
Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group
时间窗: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 4-hydroxy-cyclophosphamide (4-OH-CP), during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).
Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group
时间窗: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of VC, during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).
Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group
时间窗: Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PR, during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).
Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group
时间窗: Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PL, during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).
次要结局
未报告次要终点