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

NCT ID: NCT01031953

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2013-02-28

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.

Conditions

Breakthrough Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Fosaprepitant

Group Type: EXPERIMENTAL

fosaprepitant dimeglumine

Intervention Type: DRUG

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

systemic chemotherapy

Intervention Type: DRUG

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

survey administration

Intervention Type: OTHER

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

quality-of-life assessment

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

survey administration

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

Intervention Type: OTHER

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Joseph Bubalo

PharmD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Bubalo, PharmD, BCPS, BCOP

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

P30CA069533

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OHSU-HEM-08053-L

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000612580

Identifier Type: -

Identifier Source: org_study_id

NCT00939302

Identifier Type: -

Identifier Source: nct_alias