Malignancy
Conditions
Interventions
NK1 receptor antagonist+palonosetoron+dexamethasone day 1-3
NK1 receptor antagonist+palonosetoron+dexamethasone day 1
Sponsors
St.Marianna University School of Medicine Hospital
Graduate School of Medicine,Yokohama City University Department of Biostatistics and Epidemiology Center for Advanced Medicine and Clinical Research, Nagoya University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients receiving highly emetogenic chemotherapy (cisplatin>=50mg/m2 or combination of anthracycline and cyclophosphamide) only day1 (2) Patients receiving highly emetogenic chemotherapy for malignant disease (3) Patients >=20 years old who can be obtained informed consent. (4) G0 of nausea and vomiting by CTCAE ver4.0 within 24 houres before entry (5) Eastern Cooperative Oncology Group(ECOG)performance status(PS) of 0 or 1 (6) Adequate organ function defined as;(each of following values are examined within 2 weeks prior to entry) ALT 100<=IU/L AST 100<=IU/L T-Bil 2.0<=mg/dL Cr 1.5<=mg/dL (7) Patient with more than three months of life expectancy. (8) All subjects must be provided written informed consent prior to entry (including QOL questionnaire).
Exclusion criteria
Exclusion criteria: (1) Hematopoietic malignancy (2) Known brain metastasis (3) Patients who cannot use cortico steroid (4) Patients taking systemic corticosteroid (topical and inhaled steroid are allowed). (5) Patients with a history of administration of highly emetogenic chemotherapy (6) Patients scheduled to receive moderately to highly emetogenic chemotherapy six days before and six after the day of highly emetogenic agent administration. (Minimally to low emetogenic agents are allowed). (7) Patients with history of or scheduled to receive radiation therapy to abdomen (below diagphram) or to pelvis from six days before chemotherapy to six days after chemotherapy. (8) Patient taking antiemetics other than study drug. (9) Patients who had a hypersensitivity reaction to NK1 receptor antagonist or palonosetoron or dexamethasone (10) Patients who are intolerant to chemotherapy (11) Pregnant, breastfeeding or expecting woman (12) Patients with uncontrolled diabetes (13) HBs are positive (14) Patients with active infection (15) Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with complete response (no vomiting and no rescue medication use) during the 120 hours observation period after the infusion of chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Complete response rate during acute phase (0-24hr) and delayed phase (24-120hr). (2) Severity of nausea on/using Likert scale from day1 to 5 study period. (3) Adverse events related to steroid administrarion. (4) Quality of life score using EORCT QLQ-C30 on the day before chemotherapy administration and overall five days study period. (5) Adverse events defined as grade3 or higher/more on CTCAE ver 4.0 | — |
Countries
Japan
Contacts
Public ContactYuka Ito
St.Marianna University School of Medicine Hospital Department of Pharmacy
Outcome results
None listed