Malignant tumor (lung cancer,gastric cancer,esophagus cancer,cervical cancer,endometrial cancer,head and neck cancer,etc)
Conditions
Interventions
granisetron1mg+dexamethasone(d1-4)+aprepitant(d1-3)
palonosetron0.75mg+dexamethasone(d1-4)+aprepitant(d1-3)
Sponsors
Pharma Valley Center,Shizuoka Organization for Creation Industries
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)malignant tumor patients except for hematopoietic malignancy (2)performance status(ECOG PS) of 0-2 (3)20 years-old over at the time of giving informed consent (4)patients who receive the chemotherapy involving cisplatin as first line (5)dose of cisplatin is 50mg/m2 over (6)the regimens involve the standard treatment for vomiting with dexamethasone,aprepitant and 5HT3 receptor antagonist (7)adequate organ function as defined by;(each of the following values are examined within 8days before prior to entry) AST 100 <=IU/L ALT <= 100IU/L T-Bill <= 2.0 mg/dL Ccr >= 60 mL/min (8)all subjects must be able to provide informed,written consent prio to entry
Exclusion criteria
Exclusion criteria: (1)known prior severe hypersensitivity to 5HT3 receptor antagonist, corticosteroids and aprepitant (2)patients who do not have enough whole body state to the antineoplastic agents treatment (3)known symptomatic brain metastasis (4)patients who has a convulsive disorders that need anticonvulsants therapy (5)patients with a symptom who has ascites or pleural effusion that need puncture (6)patients with obstruction of gastrointestinal tract,for example gastric outlet or ileus etc (7)pregnant, breastfeeding or expecting woman (8)patients enforced radiotherapy at the bottom of diaphragm on the period between 6 days before and 6 days after of the date of first therapy (9)patients who take a medicine regularly ,for example , 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers,antihistamine drugs, benzodiazepine,agents, etc (10)judged by the investigator to be inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate of vomiting within 120hours from cisplatin administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.complete control rate of events associated with vomiting within 120hours from cisplatin administrated 2.total control rate of nausea and vomiting within 120hours from cisplatin administrated 3.time to treatment failure:TTF 4.adverse event | — |
Countries
Japan
Contacts
Public ContactKenichi Suzuki
Japanese foundation for cancer research Cancer Institute Hospital Department of Pharmacy
Outcome results
None listed