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 2

• Conditions: germ cell tumors

• Registration Number: JPRN-UMIN000004202
• Lead Sponsor: Kobe University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-05
• Study Completion: 2015-02-28
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 ).

Secondary Outcome Measures

Name	Time	Method
(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.