Unique ID issued by UMIN | UMIN000013082 |
---|---|
Receipt number | R000015186 |
Scientific Title | A phase II trial of palonosetron and 1-day dexamethasone and 3-day aprepitant to prevent nausea and vomiting in patients receiving paclitaxel and carboplatin |
Date of disclosure of the study information | 2014/02/05 |
Last modified on | 2017/02/09 16:25:36 |
A phase II trial of palonosetron and 1-day dexamethasone and 3-day aprepitant to prevent nausea and vomiting in patients receiving paclitaxel and carboplatin
PALODEX-A trial
A phase II trial of palonosetron and 1-day dexamethasone and 3-day aprepitant to prevent nausea and vomiting in patients receiving paclitaxel and carboplatin
PALODEX-A trial
Japan |
patients receiving paclitaxel and carboplatin for gynecologic malignancies
Medicine in general |
Malignancy
NO
Evaluation of the efficacy of aprepitant and palonosetron and dexamethasone in patients receiving pal\clitaxel and carboplatin for gynecologic malignancies.
Efficacy
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
day1 aprepitant 125mg + palonosetron 0.75mg + dexamethazone20mg
day2 aprepitant 80mg
day3 aprepitant 80mg
20 | years-old | <= |
Not applicable |
Female
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
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
70
1st name | |
Middle name | |
Last name | Naoto Furukawa |
Nara Medical University
Department of Obstetrics and Gynecology
840 Shijo-cho, Kashihara
0744-22-3051
furunao@naramed-u.ac.jp
1st name | |
Middle name | |
Last name | Fuminori Ito |
Nara Medical University
Department of Obstetrics and Gynecology
840 Shijo-cho, Kashihara
0744-22-3051
f_ito_0624@yahoo.co.jp
Nara Medical University
none
Other
NO
2014 | Year | 02 | Month | 05 | Day |
Published
Completed
2014 | Year | 01 | Month | 29 | Day |
2014 | Year | 02 | Month | 05 | Day |
2016 | Year | 02 | Month | 28 | Day |
2016 | Year | 03 | Month | 01 | Day |
2016 | Year | 03 | Month | 14 | Day |
2016 | Year | 07 | Month | 18 | Day |
2014 | Year | 02 | Month | 05 | Day |
2017 | Year | 02 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015186