Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy

This study has been terminated.
(Drug contract timelines and inadequate enrollment)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01031953
First received: December 13, 2009
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

RATIONALE: Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.

PURPOSE: This clinical trial is studying the side effects of fosaprepitant dimeglumine and to see how well it works in treating patients with nausea and vomiting caused by chemotherapy.


Condition Intervention Phase
Breakthrough Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Drug: fosaprepitant dimeglumine
Drug: systemic chemotherapy
Other: survey administration
Procedure: quality-of-life assessment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale [ Time Frame: Baseline to 2 hours after study drug administered. ] [ Designated as safety issue: No ]
    The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 2 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 2 hours from baseline would be considered in this outcome measure.


Secondary Outcome Measures:
  • Improvement in Nausea Score From Baseline to 12 Hours [ Time Frame: Baseline to 12 hours after study drug administered. ] [ Designated as safety issue: No ]
    The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 12 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 12 hours from baseline would be considered in this outcome measure.

  • Improvement in Nausea Score From 2 Hours to 24 Hours [ Time Frame: 2 hours to 24 hours after study drug administered. ] [ Designated as safety issue: No ]
    The outcome measure is the number of participants that self report improvement in a nausea score from 2 hours after receiving fosaprepitant to 24 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant reporting a lower value on the scale at the 12 or 24 hour time point would be considered in this outcome measure.

  • Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours [ Time Frame: Baseline to 24 hours after study drug administered. ] [ Designated as safety issue: No ]
    Participants were asked to report any episodes of vomiting before (baseline) and up to 24 hours after receiving Fosaprepitant. The outcome considers the number of participants reporting any episodes of emesis after receiving Fosaprepitant.

  • Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure) [ Time Frame: 2 hours after administration of Fosaprepitant 150 mg IV ] [ Designated as safety issue: No ]
    Participants with persistent nausea/vomiting after 2 hours and who desired further treatment, received standard rescue therapy at the discretion of provider with prochlorperazine, metoclopramide or haloperidol with or without additional lorazepam until relief

  • Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required) [ Time Frame: up to 24 hours after receiving fosaprepitant ] [ Designated as safety issue: No ]
    The recommended dose Fosaprepitant (MK-0517) is 115 mg administered intravenously 30 minutes before chemotherapy treatment. In this study, a 150 mg dose will be given to study patients as rescue therapy after chemotherapy only in the event of breakthrough nausea or vomiting. Those participants who did not report episodes of emesis or did not require additional rescue medications are measured in this outcome

  • Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant [ Time Frame: up to 24 hours after study drug administered. ] [ Designated as safety issue: No ]
    Participants meeting this outcome self report experiencing drowsiness at any of the study time points (2, 12 or 24 hours after receiving fosaprepitant).

  • Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness [ Time Frame: up to 24 hours after study drug administered. ] [ Designated as safety issue: Yes ]
    Participants who self report pain/soreness at drug infusion site, headache, or dizziness at any of the study time points (2, 12, or 24 hours after receiving fosaprepitant) are measured in this outcome.


Enrollment: 34
Study Start Date: August 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fosaprepitant Drug: fosaprepitant dimeglumine
A 150 mg dose will be given to study patients as rescue therapy after chemotherapy only in the event of breakthrough nausea or vomiting.
Drug: systemic chemotherapy
Patients will receive chemotherapy on Day 1 of their scheduled therapeutic regimen in combination with the pre-defined standard 5-Hydroxytryptamine-3 (5HT3) antagonist, corticosteroid regimen, with or without benzodiazepine based on published guidelines3 or as clinically indicated
Other: survey administration
Prior to the first dose of chemotherapy patients will be instructed on how to complete their patient diary
Procedure: quality-of-life assessment
Patients will also be provided the Functional Living Index - Emesis (FLIE) quality of life survey to be completed at time zero and then after 24 hours

Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the efficacy and safety of fosaprepitant dimeglumine in patients with breakthrough chemotherapy-induced nausea and vomiting (CINV) after failing prophylactic antiemetic therapy.

Secondary

  • To evaluate toxicity and serious adverse events associated with this regimen in these patients.
  • To evaluate the ability of patients to tolerate oral intake.
  • To evaluate the health-related quality of life of patients treated with this regimen.
  • To evaluate specific side effects associated with this regimen, including pain sensation and/or soreness at the infusion site, headache, dizziness, and somnolence, in these patients .
  • To refine the study design for future phase II and III studies of rescue therapy for breakthrough CINV using various secondary endpoints.

OUTLINE: Patients receive chemotherapy in combination with a pre-defined standard 5-Hydroxytryptamine-3 (5-HT3) antagonist or corticosteroid regimen with or without a benzodiazepine on day 1. If breakthrough nausea or vomiting occurs, patients then receive fosaprepitant dimeglumine IV once per standard administration guidelines. Patients with treatment response may receive additional doses of oral aprepitant once on days 2 and 3. Patients with persistent nausea/vomiting after 2 hours and who desire further treatment may receive standard rescue therapy with prochlorperazine, metoclopramide, or haloperidol with or without additional lorazepam until relief, at the discretion of the provider.

Patients complete a diary at baseline, and then at 2, 12, and 24 hours that includes a Visual Analogue Scale (VAS) for nausea; VAS for sedation; and questions about emesis and retching frequency, headache, dizziness, somnolence, and ability to take food and liquids orally. Patients also complete the Functional Living Index-Emesis Quality of Life survey at baseline and at 24 hours.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer
  • Scheduled to receive inpatient chemotherapy containing at least moderately emetogenic agents

    • May be given for adjuvant, neoadjuvant, curative, or palliative intent
    • May be given orally, IV, or by continuous infusion on ≥ 1 day
  • Scheduled to receive 5-HT3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, palonosetron, dolasetron mesylate, or dexamethasone with or without a benzodiazepine) on the day of chemotherapy
  • Self-report of at least mild nausea (for which the patient feels needs rescuing) or moderate nausea (a score of ≥ 2 on a 4-point Likert scale) OR has had ≥ 1 episode of emesis since receiving chemotherapy
  • No history of chronic nausea and/or vomiting (without chemotherapy), anticipatory nausea and/or vomiting, or emesis within 24 hours before chemotherapy
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

  • Able to understand English
  • Not pregnant or nursing
  • Negative pregnancy test
  • No clinical evidence of current or impending bowel obstruction (i.e., tumor pressing on the bowel)
  • No allergy or intolerance to study drugs

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior chemotherapy allowed
  • No aprepitant as prophylaxis or rescue treatment during the current course of chemotherapy (other than as a part of study therapy)
  • Not scheduled to receive a dopamine antagonist after chemotherapy
  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: NCT01031953

Locations
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Joseph Bubalo, PharmD, BCPS, BCOP OHSU Knight Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01031953     History of Changes
Obsolete Identifiers: NCT00939302
Other Study ID Numbers: CDR0000612580, P30CA069533, OHSU-HEM-08053-L
Study First Received: December 13, 2009
Results First Received: October 10, 2013
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:
nausea and vomiting
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 23, 2014