Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)

Study Overview
=================
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.

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

Conditions
-----------------
Chemotherapy-induced Nausea and Vomiting (CINV)

Intervention / Treatment
-----------------
* Drug: aprepitant
* Drug: Comparator: Placebo to aprepitant
* Drug: dexamethasone
* Drug: granisetron
* Drug: dexamethasone


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aprepitant (MK-0869)<br> | Drug: aprepitant<br>* Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg<br>Drug: granisetron<br>* Day 1: IV granisetron 3 mg prior to administration of cisplatin<br>Drug: dexamethasone<br>* Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg<br>|
| Placebo Comparator: Standard Therapy<br> | Drug: Comparator: Placebo to aprepitant<br>* Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg<br>Drug: dexamethasone<br>* Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg<br>Drug: granisetron<br>* Day 1: IV granisetron 3 mg prior to administration of cisplatin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 to 120 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 to 24 hours | 
| 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. | 25 to 120 hours | 
| 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). | 0 to 120 hours | 
| 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. | 0 to 24 hours | 
| 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 | 25 to 120 hours | 
| 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). | 0 to 120 hours | 
| Time to First Vomiting Episode in Cycle 1 | Time from administration of chemotherapy to first vomiting episode. | 0 to 120 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CINV