Patients with solid tumor receiving highly emetogenic chemotherapy including cisplatin.
Conditions
Interventions
Fosaprepitant 150 mg i.v. on day 1 + granisetron 1 mg i.v. on day 1 + dexamethasone 9.9mg i.v. on day 1, 6.6mg i.v. on day 2, and 13.2 mg i.v. on days 3-4.
Sponsors
Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) patients with solid tumor receiving highly emetogenic chemotherapy including cisplatin recommended 3-day course of oral aprepitant. 2) patients diagnosed with malignancy histophathologically. 3) aged 20 years or more. 4) Eeatern clinical oncology group performans status is 0 to 2. 5) fulfil all following conditions ANA >= 1,000/mm3 Plt >= 7,500/mm3 Hb>=8.0g/dl T.Bil < 2.0 g/dl AST < 2.0*ULN IU/L ALT < 2.0*UNL IU/L CCr >= 60ml/min 6) written informed consent from the patients
Exclusion criteria
Exclusion criteria: 1) patients who have need of administration of aprepitant over 4 days 2) with allergy to aprepitant 3) Possibly pregnant, or breast feeding woman 4) with Acute myocardial infaction in 6 months or with unstable ungina, congestive heart failure (NYHA >= class3), other serious cardiac disoder 5) patients with symptomatic brain metastasis 6) with hypercalcemia requiring an urgent treatment 7) patients taking medicines interacted with CYP3A4 or CYP2C9 8) with uncontrolled diabetes mellitus 9) with pleural effusion, ascitis and pericardial effusion 10) patients who are disqualified by attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate (defined as no emesis and no rescue treatment) in overall phase(0-120hr after chemotherapy). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Complete response rate in acute (0-24hr after chemotherapy) and delayed (24-120hr after chemotherapy) phases. 2) Complete control rate (defined as no nausea and no emesis and no rescue treatment) in overall, acute and delayed phases. 3) ratio of patients without nausea in overall, acute and delayed phases. 4) adverse events in 14 days after chemotherapy. 5) evaluation of volume of meal intake in acute and delayed phases. | — |
Countries
Japan
Contacts
Public ContactHozumi Kumagai
Kyushu Medical Center Department of medical oncology
Outcome results
None listed