Clinical trial NCT00952341: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy-induced Nausea and Vomiting (CINV)
Keywords: CINV
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 421
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1
timeFrame: 0 to 120 hours
Secondary outcomes:
measure: Proportion of Participants With Complete Response in the Acute Phase of Cycle 1
timeFrame: 0 to 24 hours
measure: Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1
timeFrame: 25 to 120 hours
measure: Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1
timeFrame: 0 to 120 hours
measure: Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1
timeFrame: 0 to 24 hours
measure: Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1
timeFrame: 25 to 120 hours
measure: Proportion of Participants With No Impact on Daily Life in Cycle 1
timeFrame: 0 to 120 hours
measure: Time to First Vomiting Episode in Cycle 1
timeFrame: 0 to 120 hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
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.