Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030) (EVADE)

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01405924
First received: July 28, 2011
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Nausea
Vomiting
Drug: Fosaprepitant dimeglumine
Drug: 5-HT3 RA
Drug: Dexamethasone
Drug: Rescue medication
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: EMEND® IV In Salvage Treatment of Chemotherapy-Induced Vomiting

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy [ Time Frame: Up to 120 hours following initiation of chemotherapy in Cycle 2 ] [ Designated as safety issue: No ]
    A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following chemotherapy in Cycle 2 was calculated.


Secondary Outcome Measures:
  • Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Per Type of Chemotherapy [ Time Frame: Up to 120 hours following initiation of chemotherapy in Cycle 2 ] [ Designated as safety issue: No ]
    A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following initiation of chemotherapy in Cycle 2 was calculated based on type of chemotherapy received.

  • Percentage of Participants With a Complete Response During Cycle 2 of Chemotherapy [ Time Frame: Up to 120 hours following initiation of chemotherapy in Cycle 2 ] [ Designated as safety issue: No ]
    A complete response is defined as no vomiting/no retching episodes and no use of rescue medication during the 120 hours following initiation of chemotherapy. The percentage of participants with a complete response during Cycle 2 of chemotherapy was calculated.

  • Functional Living Index - Emesis (FLIE) Total Score During Cycle 2 of Chemotherapy [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The FLIE Total Score is an 18-question quality-of-life questionnaire on the impact of nausea and vomiting (9 questions on nausea and 9 questions on vomiting) on daily life. Each question uses a visual analog scale (VAS) to rate the impact of nausea/vomiting from 1 to 7. FLIE Total Scores are calculated by summing the responses to the 18 questions and can range from 18-126 (18=a great deal of impairment, 126=no impairment), with a higher score indicating less impairment due to nausea and vomiting. "No Impact" on daily life was defined as a FLIE Total Score >108. Participants completed the FLIE questionnaire on the morning of Day 6 following initiation of chemotherapy in Cycle 2; their responses covered their experiences with nausea and vomiting over the previous 5 days.

  • Percentage of Participants With No Significant Nausea During Cycle 2 of Chemotherapy [ Time Frame: From 24 to 120 hours following initiation of chemotherapy in Cycle 2 ] [ Designated as safety issue: No ]
    Participants rated their degree of nausea in response to "How much nausea have you had over the last 24 hours?" using a 100-mm visual analog scale (VAS, 0=no nausea, 100=nausea as bad as it could be) on Days 2-6 following initiation of chemotherapy. No significant nausea was defined as VAS score <25 mm over the 24-120 hours following initiation of chemotherapy. The percentage of participants who experienced no significant nausea during Cycle 2 of chemotherapy was calculated.

  • Percentage of Participants Who Used No Rescue Medication During Cycle 2 of Chemotherapy [ Time Frame: Up to 120 hours following initiation of chemotherapy in Cycle 2 ] [ Designated as safety issue: No ]
    Participants recorded any use of rescue medication for established nausea/vomiting in their daily diaries from initiation of chemotherapy infusion through the morning of Day 6. The percentage of participants who used no rescue medication during Cycle 2 of chemotherapy was calculated.


Enrollment: 111
Study Start Date: October 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fosaprepitant 150 mg
Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy
Drug: Fosaprepitant dimeglumine
Fosaprepitant 150 mg, IV on Day 1 of chemotherapy in Cycle 2
Other Name: MK-0517, EMEND® IV
Drug: 5-HT3 RA
5-HT3 RA will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy.
Drug: Dexamethasone
Dexamethasone will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy.
Drug: Rescue medication
Rescue medication is defined as any medication used to relieve the symptoms of established nausea or vomiting. Multiple medications are permitted by the protocol and may be taken by the participant, including 5-HT3 antagonists, phenothiazines and benzodiazepines.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405924

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01405924     History of Changes
Other Study ID Numbers: 0517-030
Study First Received: July 28, 2011
Results First Received: October 24, 2014
Last Updated: October 24, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms
Signs and Symptoms, Digestive
Aprepitant
Dexamethasone
Fosaprepitant
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015