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

Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting

Sponsors

Lead Sponsor: OHSU Knight Cancer Institute

Collaborator: National Cancer Institute (NCI)

Source OHSU Knight Cancer Institute
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.

Overall Status Terminated
Start Date August 2008
Completion Date February 2013
Primary Completion Date February 2013
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale Baseline to 2 hours after study drug administered.
Secondary Outcome
Measure Time Frame
Improvement in Nausea Score From Baseline to 12 Hours Baseline to 12 hours after study drug administered.
Improvement in Nausea Score From 2 Hours to 24 Hours 2 hours to 24 hours after study drug administered.
Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours Baseline to 24 hours after study drug administered.
Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure) 2 hours after administration of Fosaprepitant 150 mg IV
Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required) up to 24 hours after receiving fosaprepitant
Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant up to 24 hours after study drug administered.
Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness up to 24 hours after study drug administered.
Enrollment 34
Condition
Intervention

Intervention Type: Drug

Intervention Name: fosaprepitant dimeglumine

Description: A 150 mg dose will be given to study patients as rescue therapy after chemotherapy only in the event of breakthrough nausea or vomiting.

Arm Group Label: Fosaprepitant

Intervention Type: Drug

Intervention Name: systemic chemotherapy

Description: 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

Arm Group Label: Fosaprepitant

Intervention Type: Other

Intervention Name: survey administration

Description: Prior to the first dose of chemotherapy patients will be instructed on how to complete their patient diary

Arm Group Label: Fosaprepitant

Intervention Type: Procedure

Intervention Name: quality-of-life assessment

Description: 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

Arm Group Label: Fosaprepitant

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Joseph Bubalo, PharmD, BCPS, BCOP Principal Investigator OHSU Knight Cancer Institute
Location
Facility: Knight Cancer Institute at Oregon Health and Science University
Location Countries

United States

Verification Date

May 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: OHSU Knight Cancer Institute

Investigator Full Name: Joseph Bubalo

Investigator Title: PharmD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Fosaprepitant

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov