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Trial record 5 of 6 for:    "Nasopharyngeal Carcinoma" | "Dexamethasone acetate"

Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy

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ClinicalTrials.gov Identifier: NCT00895245
Recruitment Status : Terminated (Study stopped due to lack of efficacy in first 6 patients)
First Posted : May 8, 2009
Results First Posted : May 18, 2017
Last Update Posted : May 18, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Keith D Eaton, University of Washington

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Nausea and Vomiting
Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Larynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Nasopharynx
Stage III Squamous Cell Carcinoma of the Oropharynx
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Larynx
Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Oropharynx
Interventions Drug: fosaprepitant dimeglumine
Drug: cisplatin
Drug: palonosetron hydrochloride
Drug: dexamethasone
Other: Functional Living Index-Emesis Questionnaire
Behavioral: Emesis Diary
Radiation: Radiotherapy
Enrollment 6
Recruitment Details Patients with Head and neck cancer being treated with concurrent cisplatin and radiotherapy were approached for study participation.
Pre-assignment Details  
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo 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.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.

Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.

fosaprepitant dimeglumine: Given IV

cisplatin: Given IV

palonosetron hydrochloride: Given IV

dexamethasone: Given IV and orally

Functional Living Index-Emesis Questionnaire: Ancillary studies

Emesis Diary: Ancillary studies

Radiotherapy: Undergo radiotherapy

Period Title: Overall Study
Started 6
Completed 0
Not Completed 6
Reason Not Completed
Lack of Efficacy             6
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo 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.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.

Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.

fosaprepitant dimeglumine: Given IV

cisplatin: Given IV

palonosetron hydrochloride: Given IV

dexamethasone: Given IV and orally

Functional Living Index-Emesis Questionnaire: Ancillary studies

Emesis Diary: Ancillary studies

Radiotherapy: Undergo radiotherapy

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
41
(39 to 51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
3
  50.0%
Male
3
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Proportion of Patients With a Complete Response to the Anti-emetic Medication Regimen
Hide Description Complete response is defined as no emesis or rescue nausea medications needed in the first 120 hours following cisplatin infusion.
Time Frame 120 hours following cisplatin infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo 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.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need 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 daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.

fosaprepitant dimeglumine: Given IV

cisplatin: Given IV

palonosetron hydrochloride: Given IV

dexamethasone: Given IV and orally

Functional Living Index-Emesis Questionnaire: Ancillary studies

Emesis Diary: Ancillary studies

Radiotherapy: Undergo r

Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Rate of Complete Response to Anti-emetic Therapy in the Delayed Setting (25-120 Hours After Cisplatin Infusion)
Hide Description [Not Specified]
Time Frame 25-120 hours following cisplatin infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo 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.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need 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 daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.

fosaprepitant dimeglumine: Given IV

cisplatin: Given IV

palonosetron hydrochloride: Given IV

dexamethasone: Given IV and orally

Functional Living Index-Emesis Questionnaire: Ancillary studies

Emesis Diary: Ancillary studies

Radiotherapy: Undergo r

Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Control of Nausea for 120 Hours Following Each Cisplatin Infusion for Multiple Cycles of Therapy as Measured by the Visual Analog Scale
Hide Description The visual analog scale ranges from 0-100. 0 is labeled as "no nausea" and 100 is labeled as "nausea as bad as it could be" A score of < 25 is considered to indicate no significant nausea. All patients discontinued trial after only one cisplatin infusion.
Time Frame 120 hours following cisplatin infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo 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.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need 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 daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.

fosaprepitant dimeglumine: Given IV

cisplatin: Given IV

palonosetron hydrochloride: Given IV

dexamethasone: Given IV and orally

Functional Living Index-Emesis Questionnaire: Ancillary studies

Emesis Diary: Ancillary studies

Radiotherapy: Undergo r

Overall Number of Participants Analyzed 6
Mean (Full Range)
Unit of Measure: millimeters
45.2
(6 to 79)
4.Secondary Outcome
Title Impact of Cisplatin-induced Nausea and Vomiting on Daily Life During the 5 Day Period Following Cisplatin Infusion for Multiple Cycles as Measured by the Functional Living Index-Emesis Questionnaire
Hide Description FLIE is a patient-completed quality of life assessment modified from the original Functional Living Index – Cancer questionnaire. FLIE contains two domains: nausea and vomiting with nine items in each domain. The first item asks the patient to rate how much nausea (or vomiting) has occurred over a 5 day period. The remaining eight items ask patients to rate the impact of nausea (or vomiting) on various aspects of a patient’s life (for example, ability to enjoy meals/liquids). Each item is answered using a 7 point visual analog scale with 7 being "none /not at all" and 1 being "a great deal". The two domains are summed for a total score with a possible range of 18-126. Higher scores indicate a more favorable quality of life. A total score of >108 defines those patients who had a minimal impact of CINV on quality of life. All particpants discontinued the trial after one cycle of cisplatin.
Time Frame 5 days following cisplatin infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients did not complete the Functional Living Index-Emesis (FLIE) Questionnaire.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo 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.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need 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 daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.

fosaprepitant dimeglumine: Given IV

cisplatin: Given IV

palonosetron hydrochloride: Given IV

dexamethasone: Given IV and orally

Functional Living Index-Emesis Questionnaire: Ancillary studies

Emesis Diary: Ancillary studies

Radiotherapy: Undergo r

Overall Number of Participants Analyzed 4
Mean (Full Range)
Unit of Measure: units on a scale
83.98
(70.81 to 98.94)
Time Frame up to 7 weeks
Adverse Event Reporting Description Only grade 2 and higher adverse events were recorded.
 
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo 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.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need 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 daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.

fosaprepitant dimeglumine: Given IV

cisplatin: Given IV

palonosetron hydrochloride: Given IV

dexamethasone: Given IV and orally

Functional Living Index-Emesis Questionnaire: Ancillary studies

Emesis Diary: Ancillary studies

Radiotherapy: Undergo r

All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Blood and lymphatic system disorders   
leukocytes  1  4/6 (66.67%)  4
Anemia  1  1/6 (16.67%)  1
Ear and labyrinth disorders   
Tinnitus  1  1/6 (16.67%)  1
Dizziness  1  1/6 (16.67%)  1
Gastrointestinal disorders   
nausea  1  5/6 (83.33%)  5
Mucositis  1  2/6 (33.33%)  2
Vomiting  1  3/6 (50.00%)  3
General disorders   
Anorexia  1  1/6 (16.67%)  1
Malaise  1  1/6 (16.67%)  1
Investigations   
Sinus Pain  1  1/6 (16.67%)  1
Metabolism and nutrition disorders   
Hypophosphatemia  1  1/6 (16.67%)  1
Nervous system disorders   
Headache  1  1/6 (16.67%)  1
Ataxia  1  1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE version 3.0
This study was terminated early due to lack of efficacy.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Keith Eaton
Organization: University of Washington
Phone: 206-288-2048
EMail: kdeaton@uw.edu
Layout table for additonal information
Responsible Party: Keith D Eaton, University of Washington
ClinicalTrials.gov Identifier: NCT00895245     History of Changes
Other Study ID Numbers: 6862
NCI-2009-01669
First Submitted: May 7, 2009
First Posted: May 8, 2009
Results First Submitted: January 9, 2017
Results First Posted: May 18, 2017
Last Update Posted: May 18, 2017