Efficacy and tolerability of combination therapy with aprepitant,palonosetron,and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy for gynecological cancer(Phase II Study) - Phase II Study of aprepitant and palonosetron to prevent nausea and vomiting induced by chemotherapy for gynecological cancer

Kansai Clinical Oncology Group -Gynecologic Cancer Group-0 sites100 target enrollmentJune 24, 2010

Overview

No summary available.

Registry

who.int

Start Date

June 24, 2010

End Date

June 1, 2012

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Sponsor

Kansai Clinical Oncology Group -Gynecologic Cancer Group-

•1\. Patients with history of chemotherapy with cisplatin. 2\. Patients with dysfunction of liver ( Child\-Pugh Score \> 9 ). 3\. Patients with received Pimozide. 4\. Patients with ALT ( GPT ) or AST ( GOT ) \> 3 X the upper limit of normal or Total bilirubin \> 2 X the upper limit of normal prior to registration. 5\. Patients with serum creatinine \> 1\.5 X the upper limit of normal prior to registration. 6\. Patients with active infection disease. 7\. Patients who needs invasive treatment for massive effusion ( Eligible in case of controlled massive effusion ). 8\. Patients with pregnant or lactating women or women of childbearing potential. 9\. Patients received last observation by another clinical study within 90 days prior to agreement acquisition. 10\. Patients who cannot, won't, or don't seem to satisfy by hospital visiting, strict observance of the experimental drug dosage, or limitation of time constraints. 11\. Patients judged inappropriate for this study by physicians.