Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)
Primary Purpose
Chemotherapy-induced Nausea and Vomiting (CINV)
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
aprepitant
Comparator: Placebo to aprepitant
dexamethasone
granisetron
dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-induced Nausea and Vomiting (CINV) focused on measuring CINV
Eligibility Criteria
Inclusion Criteria:
Cycle 1:
- Patient is scheduled to receive his/her first course of cisplatin chemotherapy at a dose of at least 70 mg/m^2 administered a maximum of 3 hours
- Patient has a predicted life expectancy of at least 3 months
- Patient is not pregnant
Cycle 2 (optional):
- Participation in the study during the next cycle of chemotherapy is considered
appropriate by the investigator and will not pose unwarranted risk to the patient.
- Satisfactory completion of the preceding cycle of chemotherapy and related
study procedures.
- Patient will continue to receive the same chemotherapy regimen as in Cycle 1. The cisplatin dose may be reduced in subsequent cycle, as long as the new
dose is still no less than 70 mg/m^2.
Exclusion Criteria:
Cycles 1 & 2:
- Patient will receive stem cell therapy in conjunction with cisplatin
- Patient has an active infection or any uncontrolled disease (e.g. diabetes)
- Patient will receive multiple-day chemotherapy with cisplatin
- Patient will receive chemotherapy of moderate or high emetogenicity on the 6 days prior to cisplatin infusion or the 6 days following the cisplatin infusion
- Patient has vomited within 24 hours prior to cisplatin infusion
- Patient received or will receive radiation therapy to the abdomen
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aprepitant (MK-0869)
Standard Therapy
Arm Description
Outcomes
Primary Outcome Measures
Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1
Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy.
Secondary Outcome Measures
Proportion of Participants With Complete Response in the Acute Phase of Cycle 1
Acute phase was defined as 0 to 24 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy.
Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1
Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy.
Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1
Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1
Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.
Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1
Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy
Proportion of Participants With No Impact on Daily Life in Cycle 1
The Functional Living Index-Emesis is a self-administered, validated emesis & nausea-specific questionnaire. Participants completed the questionnaire 5 days post chemotherapy. It had 9 questions each on nausea and vomiting. "No impact of chemotherapy-induced nausea & vomiting (CINV) on daily life" was defined as an average item score of >6 on the 7-point scale (i.e., >108 total score). The scale was in the opposite direction for questions 3, 6, 11, 15 & 18. For each question: score ranged from 1 (worst) to 7 (best, i.e., no CINV). Total score range was 7 (worst) to 126 (best).
Time to First Vomiting Episode in Cycle 1
Time from administration of chemotherapy to first vomiting episode.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00952341
Brief Title
Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)
Official Title
A Phase III, Randomized, Multi-center, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Safety, Tolerability and Efficacy of MK0869/Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With High-Dose Cisplatin
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 25, 2009 (Actual)
Primary Completion Date
April 4, 2010 (Actual)
Study Completion Date
May 5, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting (CINV)
Keywords
CINV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
421 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aprepitant (MK-0869)
Arm Type
Experimental
Arm Title
Standard Therapy
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
aprepitant
Intervention Description
Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo to aprepitant
Intervention Description
Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Intervention Type
Drug
Intervention Name(s)
granisetron
Intervention Description
Day 1: IV granisetron 3 mg prior to administration of cisplatin
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg
Primary Outcome Measure Information:
Title
Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1
Description
Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy.
Time Frame
0 to 120 hours
Secondary Outcome Measure Information:
Title
Proportion of Participants With Complete Response in the Acute Phase of Cycle 1
Description
Acute phase was defined as 0 to 24 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy.
Time Frame
0 to 24 hours
Title
Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1
Description
Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy.
Time Frame
25 to 120 hours
Title
Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1
Description
Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
Time Frame
0 to 120 hours
Title
Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1
Description
Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.
Time Frame
0 to 24 hours
Title
Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1
Description
Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy
Time Frame
25 to 120 hours
Title
Proportion of Participants With No Impact on Daily Life in Cycle 1
Description
The Functional Living Index-Emesis is a self-administered, validated emesis & nausea-specific questionnaire. Participants completed the questionnaire 5 days post chemotherapy. It had 9 questions each on nausea and vomiting. "No impact of chemotherapy-induced nausea & vomiting (CINV) on daily life" was defined as an average item score of >6 on the 7-point scale (i.e., >108 total score). The scale was in the opposite direction for questions 3, 6, 11, 15 & 18. For each question: score ranged from 1 (worst) to 7 (best, i.e., no CINV). Total score range was 7 (worst) to 126 (best).
Time Frame
0 to 120 hours
Title
Time to First Vomiting Episode in Cycle 1
Description
Time from administration of chemotherapy to first vomiting episode.
Time Frame
0 to 120 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cycle 1:
Patient is scheduled to receive his/her first course of cisplatin chemotherapy at a dose of at least 70 mg/m^2 administered a maximum of 3 hours
Patient has a predicted life expectancy of at least 3 months
Patient is not pregnant
Cycle 2 (optional):
Participation in the study during the next cycle of chemotherapy is considered
appropriate by the investigator and will not pose unwarranted risk to the patient.
Satisfactory completion of the preceding cycle of chemotherapy and related
study procedures.
Patient will continue to receive the same chemotherapy regimen as in Cycle 1. The cisplatin dose may be reduced in subsequent cycle, as long as the new
dose is still no less than 70 mg/m^2.
Exclusion Criteria:
Cycles 1 & 2:
Patient will receive stem cell therapy in conjunction with cisplatin
Patient has an active infection or any uncontrolled disease (e.g. diabetes)
Patient will receive multiple-day chemotherapy with cisplatin
Patient will receive chemotherapy of moderate or high emetogenicity on the 6 days prior to cisplatin infusion or the 6 days following the cisplatin infusion
Patient has vomited within 24 hours prior to cisplatin infusion
Patient received or will receive radiation therapy to the abdomen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
24276953
Citation
Hu Z, Cheng Y, Zhang H, Zhou C, Han B, Zhang Y, Huang C, Chang J, Song X, Liang J, Liang H, Bai C, Yu S, Chen J, Wang J, Pan H, Chitkara DK, Hille DA, Zhang L. Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial. Support Care Cancer. 2014 Apr;22(4):979-87. doi: 10.1007/s00520-013-2043-9. Epub 2013 Nov 26.
Results Reference
result
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Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)
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