A Phase II Clinical Trial Investigating the Efficacy of Single-Dose Fosaprepitant for the Prevention of Cisplatin-Induced Nausea and Vomiting (CINV) in Patients With Head & Neck Cancer Undergoing Concurrent Chemotherapy and Radiation
PRIMARY OBJECTIVES:
I. To determine the complete response rate of anti-emetic therapy based on a single dose of
intravenous fosaprepitant with multiple cycles of high dose cisplatin (complete response is
defined as no emesis or rescue nausea medications needed in the 120 hours following
cisplatin infusion).
SECONDARY OBJECTIVES:
I. To determine the complete response rate of anti-emetic therapy based on a single dose of
intravenous fosaprepitant with multiple cycles of high dose cisplatin in the delayed period
(25-120 hours following cisplatin infusion).
II. To determine efficacy of anti-emetic therapy based on a single-dose of intravenous
fosaprepitant to achieve adequate control of nausea following multiple cycles of high-dose
cisplatin as defined by a score on the visual analog scale of < 25mm in the 120 hours
following cisplatin infusion.
III. To determine the functional impact of cisplatin induced nausea and vomiting (CINV) on
daily life as measured by the Functional Living Index-Emesis (FLIE) Questionnaire total
score.
OUTLINE: Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3
courses. Patients also undergo 3-D conformal radiotherapy or intensity-modulated
radiotherapy once daily 5 days a week for up to 7 weeks.
Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and
dexamethasone IV on day 1 (prior to cisplatin infusion). Patients then receive oral
dexamethasone on days 2-4. Patients with no emesis or requirement for rescue anti-emetics in
the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as
above with the second and third courses of cisplatin.
Patients complete an emesis diary (that includes a nausea visual analog scale) daily for 5
days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis
Questionnaire on day 8 of each course of chemotherapy.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Proportion of patients with a complete response to the anti-emetic medication regimen
Up to day 27
No
Keith Eaton
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
6862
NCT00895245
February 2009
Name | Location |
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |