Unique ID issued by UMIN | UMIN000004202 |
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Receipt number | R000004997 |
Scientific Title | Study of efficacy and tolerability of combination therapy with palonosetron, aprepitant, and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with germ cell tumors undergoing multiple-day cisplatin-based chemotherapy regimen. |
Date of disclosure of the study information | 2010/09/05 |
Last modified on | 2019/11/27 12:12:57 |
Study of efficacy and tolerability of combination therapy with palonosetron, aprepitant, and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with germ cell tumors undergoing multiple-day cisplatin-based chemotherapy regimen.
Phase II study of palonosetron, aprepitant and dexamethazone to prevent nausea and vomiting induced by multiple-day emetogenic chemotherapy.
Study of efficacy and tolerability of combination therapy with palonosetron, aprepitant, and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with germ cell tumors undergoing multiple-day cisplatin-based chemotherapy regimen.
Phase II study of palonosetron, aprepitant and dexamethazone to prevent nausea and vomiting induced by multiple-day emetogenic chemotherapy.
Japan |
germ cell tumors
Urology |
Malignancy
NO
We evaluate efficacy and tolerability of combination therapy with palonosetron, aprepitant, and dexamethasone in patients receiving multiple-day cisplatin-based chemotherapy regimen.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
The proportion of patients with complete response (CR : no vomiting and no use of rescue therapy ) in the overall phase ( 0-240 hour after administration of cisplatin ).
(1)The proportion of patients with complete protection (no vomiting and no use of rescue therapy, no significant nausea) in the acute phase( 0-120 hour after administration of cisplatin ) and delayed phase ( 120-240 hour after administration of cisplatin ).
(2)Time to first vomiting.
(3)The proportion of patients with total control (no vomiting and no use of rescue therapy, no nausea)in the acute phase and delayed phase.
(4)The proportion of patients without vomiting (including patients with no use of rescue therapy) in the acute phase and delayed phase.
(5)The frequency of vomiting.
(6)No significant nausea.
(7)The proportion of patients without nausea in the acute phase and delayed phase.
(8)The degree of nausea.
(9)The proportion of patients without a rescue therapy in the acute phase and delayed phase.
(10)Time to first use of rescue therapy.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
palonosetron 0.75mg (day 1)(iv)
aprepitant 125mg (day 1)(oral)
aprepitant 80mg (day 2-7)(oral)
dexamethasone 6.6mg (day 1-7)(iv)
20 | years-old | <= |
Not applicable |
Male and Female
1)20 Years and older
2)Patients scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy in hospitalization.
3)Performance Status : 0-2
4)Life expectancy of at least 3 months
5)Patient can be described accurately symptom diary.
6)WBC ; 3,000/mm3 and Absolute Neutrophil Count (ANC); 1,500/mm3
Platelets ; 100,000/mm3
Aspartate aminotransferase (AST, SGOT) and Alanine aminotransferase (ALT, SGPT) < 2.5 x upper limit of normal
Bilirubin < 1.5 x upper limit of normal
Serum Creatinine < 1.5 x upper limit of normal
7)Patient will provide written informed consent and authorization to release personal health information.
1)Patients treated with stem cell transplantation in parallel with cisplatin chemotherapy.
2)No use of another antiemetic agent within 48 hours prior to beginning chemotherapy.
3)No use of benzodiazepine or opioids within 48 hours prior to beginning chemotherapy.
4)No use of systemic steroids within 72 hours prior to beginning chemotherapy.
5)No apply of radiotherapy within day -6 to 10.
6)No vomiting within 24 hours prior to beginning chemotherapy.
7)No known CNS metastasis.
8)No use of agents which may impair metabolism of aprepitant which include: Cisapride, macrolide antibiotics Clarithromycin, azole antifungal agents (Ketoconazole, Itraconazole)
9)No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Phenytoin, Carbamazepine, and barbiturates.
10)Subject with uncontrolled diabetes or a concurrent illness/condition requiring chronic systemic steroids.
11)No known hypersensitivity to any component of study regimen.
12)Patients judged inappropriate for this study by physicians.
25
1st name | |
Middle name | |
Last name | Midori Hirai |
Kobe University Hospital
Department of Hospital Pharmacy
7-5-2 kusunoki-cho Chuo-ku Kobe Hyogo 650-0017 JAPAN
078-382-6669
ioroit@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Takeshi Ioroi |
Kobe University Hospital
Department of Hospital Pharmacy
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
078-382-6669
chiken@med.kobe-u.ac.jp
Kobe University Hospital
Kobe University Hospital
Other
NO
2010 | Year | 09 | Month | 05 | Day |
Published
https://link.springer.com/article/10.1007%2Fs00520-017-3967-2
Twenty-five patients were enrolled and evaluated for safety, and 24 patients were evaluated for efficacy. CR was achieved in 62.5% of patients (95% confidence interval [CI]?=?40.6-81.2, p?=?0.043) in the overall period. CP and TC were achieved in 62.5% (95% CI?=?40.6-81.2) and 25.0% of patients (95% CI?=?9.8-46.7), respectively, in the overall period. The primary adverse drug reaction was hiccups (48.0%). The events were expected, and none was grade 3 or 4.
Completed
2010 | Year | 09 | Month | 01 | Day |
2010 | Year | 10 | Month | 26 | Day |
2010 | Year | 11 | Month | 01 | Day |
2015 | Year | 02 | Month | 28 | Day |
2015 | Year | 05 | Month | 31 | Day |
2015 | Year | 07 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2010 | Year | 09 | Month | 14 | Day |
2019 | Year | 11 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004997
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