Clinical trial NCT01405924: Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030)
Official title: EMEND® IV In Salvage Treatment of Chemotherapy-Induced Vomiting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nausea
Vomiting
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-07-29
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will assess the efficacy of a single dose of intravenous (IV) fosaprepitant (MK-0517, EMEND® IV) as salvage therapy when added to a 5-hydroxytryptamine receptor 3 antagonist (5-HT3 RA) and dexamethasone for the prevention of chemotherapy-induced vomiting (CIV) in participants who experienced CIV in the first cycle of moderately emetic chemotherapy (MEC). The primary hypothesis is that there will be no vomiting and no retching in at least 20% of participants during the second cycle of MEC in participants who previously experienced vomiting during the first cycle of MEC.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with either breast or gynecological cancer
* Receiving either AC-like or CT MEC
* Experienced at least 1 episode of vomiting or retching during the first 5 days following Cycle 1 of chemotherapy that was thought to be due to chemotherapy. Received standard chemotherapy-induced nausea and vomiting (CINV) prophylaxis not containing aprepitant or fosaprepitant
* No change in chemotherapy at Cycle 2
* No change in Cycle 1 antiemetic regimen at Cycle 2
* Eastern Cooperative Oncology Group (ECOG) status 0-1

Exclusion Criteria:

* Requires increase in systemic corticosteroid therapy
* Used benzodiazepines or opiates in the 48 hours prior to Cycle 2 chemotherapy
* Received or will receive radiation therapy to the abdomen or pelvis in the week prior to Visit 1 or in Days 1-6 following chemotherapy
* Vomited in the 24 hours prior to Treatment Day 1
* Pregnant or breast-feeding
* Participating in a study with aprepitant or fosaprepitant or has taken an investigational drug in the last 4 weeks
* Symptomatic central nervous system metastasis
* History of other malignancies in the last 2 years

Primary outcomes:
measure: Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy
timeFrame: Up to 120 hours following initiation of chemotherapy in Cycle 2
Secondary outcomes:
measure: Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Per Type of Chemotherapy
timeFrame: Up to 120 hours following initiation of chemotherapy in Cycle 2
measure: Percentage of Participants With a Complete Response During Cycle 2 of Chemotherapy
timeFrame: Up to 120 hours following initiation of chemotherapy in Cycle 2
measure: Functional Living Index - Emesis (FLIE) Total Score During Cycle 2 of Chemotherapy
timeFrame: From Day 1 (prior to initiation of chemotherapy in Cycle 2) to morning of Day 6 (up to ~120 hours following initiation of chemotherapy in Cycle 2)
measure: Percentage of Participants With No Significant Nausea During Cycle 2 of Chemotherapy
timeFrame: From 24 to 120 hours following initiation of chemotherapy in Cycle 2
measure: Percentage of Participants Who Used No Rescue Medication During Cycle 2 of Chemotherapy
timeFrame: Up to 120 hours following initiation of chemotherapy in Cycle 2
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: