malignant tumor(only solid tumor)
Conditions
Interventions
Sponsors
University of Shizuoka, School of Pharmaceutical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with malignant tumor except for hematopoietic malignancy 2) Patients who are over 20 years old at thetime of registration 3) Cisplatin-naive solid malignant tumor patients who will receive cisplatin (>=50 mg/m2)-based chemotherapy 4) Eastern Cooperative Oncology Group(ECOG) performance status(PS) of 0, 1 or 2 5) Patients who have adequate organ functions <Each of the following values are examined within 2 weeks before registration for this study> ALT < 100 U/L AST < 100 U/L T-Bil < 2.0 mg/dL CCr >= 55 mL/min 6) Patients who got written informed consent prior to registration
Exclusion criteria
Exclusion criteria: 1) Patients who has history of hypersensitivity or allergy for study drugs or similar compounds. 2) Patients taking systemic corticosteroid (oral and intravenous) except for inhaled or topical corticosteroid preparation 3) Patients having a clear vomiting symptom such as brain metastasis or gastrointestinal obstruction to the passage of foods 4) Patients with symptomatic ascites or pleural effusions requiring therapeutic puncture 5) Patients with obstruction of gastrointestinal tract, for example gastric outlet or ileus etc. 6) Patients who have convulsive disorders requiring anticonvulsants therapy 7) Patients receieving adrenaline or pimozide 8) Patients who start taking opioids within 48 h prior to registration 9) Patients who received radiation therapy to abdomen or pelvis within 6 days prior to registration or will receive radiation therapy until 6 days after cisplatin administration 10) Patients regularly taking antiemetics other than study drugs 11) Patients who cannot be hospitalized after administration of cisplatin during 6 days 12) Pregnant, breastfeeding or expecting women or who do not wish to use contraception 13) Patients with diabetes mellitus receiving treatment of antidiabetic agents or having HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1 within 28 days before registration 14) Patients with smoking habit 15) Patients who are judged to be inappropriate for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Control (no vomiting/retching, no rescue medication, and no nausea) proportion within 120 hours after the initiation of cisplatin administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. TC proportion during acute phase (0-24 h) and delayed phase (24-120 h) 2. Complete response (CR: no vomiting/retching, no rescue medication) proportion for the overall phase, the acute phase and the delayed phase 3. Complete control (CC: no vomiting/retching, no rescue medication, and no more than mild nausea) proportion for the overall phase, the acute phase and the delayed phase 4. The proportion of "no nausea" for the overall phase, the acute phase and the delayed phase 5. Time to treatment failure 6. Adverse events 7. Relationship between antiemetic efficacy and pharmacogenomic biomarkers (Exploratory analysis) | — |
Countries
Japan
Contacts
Public ContactDaiki TSUJI
University of Shizuoka School of Pharmaceutical Sciences, Department of Clinical Pharmacology & Genetics
Outcome results
None listed