Clinical trial NCT01031953: Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy
Official title: Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Breakthrough Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: nausea and vomiting
unspecified adult solid tumor, protocol specific
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-12-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale
timeFrame: Baseline to 2 hours after study drug administered.
Secondary outcomes:
measure: Improvement in Nausea Score From Baseline to 12 Hours
timeFrame: Baseline to 12 hours after study drug administered.
measure: Improvement in Nausea Score From 2 Hours to 24 Hours
timeFrame: 2 hours to 24 hours after study drug administered.
measure: Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours
timeFrame: Baseline to 24 hours after study drug administered.
measure: Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure)
timeFrame: 2 hours after administration of Fosaprepitant 150 mg IV
measure: Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required)
timeFrame: up to 24 hours after receiving fosaprepitant
measure: Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant
timeFrame: up to 24 hours after study drug administered.
measure: Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness
timeFrame: up to 24 hours after study drug administered.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Knight Cancer Institute at Oregon Health and Science University
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Joseph Bubalo, PharmD, BCPS, BCOP
role: PRINCIPAL_INVESTIGATOR
References: