Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Inj. Fosaprepitant: Group B (Fosaprepitant arm)
1. Patients in Fosaprepitant arm less than 12 years:
Fosaprepitant: Single-dose on day 1, 4mg/kg, maximum 150mg, infused IV over 1 hour,
Sponsors
Prof Sameer Bakhshi
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 5 years to =15kg 2. Patients with pathologically confirmed malignancies 3. Chemo-naïve 4. Scheduled to receive first cycle of HEC 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 6. ECOG PS 3 due to the underlying malignancy 7. Childrenâ??s caregiver(s) can understand Hindi or English, and are willing for participation in the study and for follow-up
Exclusion criteria
Exclusion criteria: 1. Vomiting, retching, or more than mild nausea within 24 hours before the start of chemotherapy 2. Any history of CNS disease including brain metastasis, seizure disorder or psychosis 3. Significant organ dysfunction: SGOT/ SGPT >2.5x ULN, S. bilirubin >1.5x ULN, S. creatinine >1.5x ULN 4. Active infection or uncontrolled medical condition other than malignancy 5. Not willing to participate in the study 6. Need for contraindicated concomitant medication (pimozide, terfenadine, astemizole, or cisapride) 7. Need for medication that strongly induces CYP3A4 activity (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital) 8. Patients on systemic steroids other than for use as an antiemetic agent 9. Prior aprepitant/fosaprepitant use 10. Received radiotherapy to abdomen, pelvis, cranium, or craniospinal regions, in the week prior to treatment initiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients in IV fosaprepitant or oral aprepitant arms who achieve a complete response (defined as no vomiting, no retching, and no use of rescue medications) during the acute phase of the first cycle of Highly-Emetogenic chemotherapyTimepoint: Acute phase (from the initiation of chemotherapy till 24 hours after the completion of the last dose of chemotherapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of nausea and vomiting during acute, chronic, and overall phases in each armTimepoint: Acute phase (from the initiation of chemotherapy till 24 hours after the completion of the last dose of chemotherapy) Delayed phase (24 to 120 hours after the completion of the last dose of chemotherapy) Overall phase (From initiation of chemotherapy to 120 hours after the completion of the last dose of chemotherapy) ;Incidence and spectrum of side-effects in each armTimepoint: Overall phase (From initiation of chemotherapy to 120 hours after the completion of the last dose of chemotherapy) ;Proportion of patients achieving CR in each arm in single-day vs. multi-day chemotherapy regimens, during acute, delayed, and overall phasesTimepoint: Acute phase (from the initiation of chemotherapy till 24 hours after the completion of the last dose of chemotherapy) Delayed phase (24 to 120 hours after the completion of the last dose of chemotherapy) Overall phase (From initiation of chemotherapy to 120 hours after the completion of the last dose of chemotherapy) ;Proportion of patients in each arm who achieve complete response during the delayed phase and overall phase of the first cycle of Highly-Emetogenic chemotherapyTimepoint: Delayed phase (24 to 120 hours after the completion of the last dose of chemotherapy) Overall phase (From initiation of chemotherapy to 120 hours after the completion of the last dose of chemotherapy);Proportion of patients requiring rescue anti-emetics in single-day and multi-day chemotherapy regimens, during acute, delayed, and overall phasesTimepoint: Acute phase (from the initiation of chemotherapy till 24 hours after the completion of the last dose of chemotherapy) Delayed phase (24 to 120 hours after the completion of the last dose of chemotherapy) Overall phase (From initiation of chemotherapy to 120 hours after the completion of the last dose of chemotherapy) | — |
Countries
India
Contacts
Public ContactDr Azgar Abdul Rasheed
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed