patients with gynecological malignancies who are receiving paclitaxel/carboplatin.
Conditions
Interventions
day1 palonosetron0.75mg plus dexamethazone20mg day2,3 dexametazone8mg
day1 palonosetron0.75mg plus dexamethazone20mg
Sponsors
Nara Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Gynecological malignacies confirmed by histology. 2.No previous history of receiving chemotherapy. 3.Receiving paclitaxel175mg/m2 plus carboplatin AUC=5. 4.Adequate bone marrow,liver,and renal functions. 5.Performance Status 0-1 6.written informed consent
Exclusion criteria
Exclusion criteria: 1.Serious complication as followings; interstitial pneumonia; pulmonary fibrosis; heartfailure; renal failure; hepatic failure; uncontrolled diabetes mellitus etc. 2.Patients with symptomatic brain metastasis. 3.Receiving antiseizure medications. 4.Severe ascites and / or pleural effusion. 5.Bowel obstruction. 6.Symptom of emesis. 7.Hypersensitivity to have a history palonosetron and / or other 5-HT3 receptor antagonists. 8.Hypersensitivity to have a history dexamethazone. 9.Pregnancy or lactation. 10.Previous history of receiving palonosetron. 11.Inappropriate patients for this study judged by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is complete response( no emetic episodes and no rescue medication) in delayed chemotherapy-induced nausea and vomiting. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are complete response in acute and overall chemotherapy-induced nausea and vomiting, and complete cntrol( no emetic episodes, no use of rescue medication, and no nausea), grade of nausea, and incidence of side effects in acute, delayed and overall chemotherapy-induced nausea and vomiting. | — |
Countries
Japan
Contacts
Public ContactNaoto Furukawa
Nara Medical University Department of Obstetrics and Gynecology
Outcome results
None listed