nausea and vommitting associated with emetogenic chemotherapy
Conditions
Interventions
GROUP 1
Patients 12 to 17 years of age:
Day 1: aprepitant 125 mg capsule PO + ondansetron
Days 2-3: aprepitant 80 mg capsule PO
Patients 6 months to
Sponsors
Merck Sharp & Dohme (MSD)
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, 6 months to 17 years of age. 2. Patient is scheduled to receive chemotherapeutic agent(s) associated with moderate, high risk or very high risk of emetogenicity for a documented malignancy, or a chemotherapy regimen not previously tolerated due to vomiting. 3. Patient with documented malignancy at either original diagnosis or relapse; 4. Patient is expected to receive ondansetron as part of their antiemetic regimen. 5. Patient aged >10 years has a Karnofsky score >= 60; patient aged = 60 .
Exclusion criteria
Exclusion criteria: 1. Patient is scheduled to receive stem cell rescue therapy in conjunction with study related course(s) of emetogenic chemotherapy.;2. Patient has a symptomatic primary or metastatic CNS malignancy causing nausea and/or vomiting. Patient who is asymptomatic is allowed to participate.;3. Patient has abnormal laboratory values as follows : a. Bone Marrow Function - Peripheral absolute neutrophil count (ANC) 5.0 x upper limit of normal (ULN) for age - ALT>5.0 x upper limit of normal (ULN) for age - Bilirubin > 1.5 x upper limit of normal (ULN) for age c. Renal function - A serum creatinine > 1.5 x upper limit of normal (ULN) for age;4. Patient has been started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is planned to receive a corticosteroid as part of the chemotherapy regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response (no vomiting and no use of rescue medication) in the 120 hours following the initiation of emetogenic chemotherapy in Cycle 1 (overall phase). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Complete Response in the 0 to 24 hours following the initiation of emetogenic chemotherapy in Cycle 1 (acute phase). - Complete Response in the 25 to 120 hours following the initiation of emetogenic chemotherapy in Cycle 1 (delayed phase). - No Vomiting, regardless of rescue medication use, in the 120 hours following the initiation of emetogenic chemotherapy in Cycle 1 (overall phase). - safety and tolerability of the three-day oral aprepitant regimen in patients from 6 months to 17 years of age who are receiving emetogenic chemotherapy in Cycle 1. | — |
Countries
Netherlands
Outcome results
None listed