patients receiving paclitaxel and carboplatin for gynecologic malignancies
Conditions
Interventions
day1 aprepitant 125mg + palonosetron 0.75mg + dexamethazone20mg day2 aprepitant 80mg day3 aprepitant 80mg
Sponsors
Nara Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Age >=20 years old 2.Gynecological malignacies confirmed by histology. 3.No previous history of receiving chemotherapy. 4.Receiving paclitaxel175mg/m2 plus carboplatin AUC=5. 5.Adequate bone marrow,liver,and renal functions. WBC >=3000/mm3 Hb >=9.0g/dl Platelet >=100000/mm3 AST, ALT=<100IU/l Total bilirubin=<1.5mg/dl Creatinin=<1.2mg/dl 6.Performance Status 0-1 7.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 aprepitant and / or palonosetron and / or other 5-HT3 receptor antagonists and / or Hypersensitivity to have a history dexamethazone. . 8.Receiving pimozide 9.Pregnancy or lactation. 10.Previous history of receiving aprepitant and / or palonosetron. 11.Patient who doesn't have ability or intention that cooperates for procedure of the study 12.Inappropriate patients for this study judged by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of delayed complete response (CR), defined as no vomiting with no rescue medication for 24-120 h from the start of the first cycle of paclitaxel and carboplatin. | — |
Countries
Japan
Contacts
Public ContactFuminori Ito
Nara Medical University Department of Obstetrics and Gynecology
Outcome results
None listed