Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy
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.
Breakthrough Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Drug: fosaprepitant dimeglumine
Drug: systemic chemotherapy
Other: survey administration
Procedure: quality-of-life assessment
|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|
- 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 ]
- Change in nausea score from baseline to 12 hours [ Time Frame: Baseline to 12 hours after study drug administered. ] [ Designated as safety issue: No ]
- Change in nausea score from 2 hours to 12 and 24 hours [ Time Frame: 2 hours to 12 and 24 hours after study drug administered. ] [ Designated as safety issue: No ]
- Change in quality-of-life score from baseline to 24 hours [ Time Frame: Baseline to 24 hours after study drug administered. ] [ Designated as safety issue: No ]
- Number of vomiting episodes from baseline to 2, 12, and 24 hours [ Time Frame: Baseline to 2, 12, and 24 hours after study drug administered. ] [ Designated as safety issue: No ]
- Time until 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 ]If the patient has persistent nausea/vomiting after 2 hours and desire further treatment, they will receive standard rescue therapy at the discretion of provider with prochlorperazine, metoclopramide or haloperidol with or without additional lorazepam until relief
- Percentage of patients achieving a complete response (no emesis, no additional rescue medication required) [ Time Frame: 24 hours after chemotherapy ] [ 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.
- Percentage of patients with increased fatigue or sedation at 2, 12, and 24 hours [ Time Frame: 2, 12, and 24 hours after study drug administered. ] [ Designated as safety issue: No ]
- Percentage of patients with specific side effects, including pain sensation/soreness at the infusion site, headache, and dizziness [ Time Frame: After study drug administered. ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2008|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
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 5HT3 antagonist, corticosteroid regimen, with or without benzodiazepine based on published guidelines3 or as clinically indicatedOther: survey administration
Prior to the first dose of chemotherapy patients will be instructed on how to complete their patient diaryProcedure: 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
- To evaluate the efficacy and safety of fosaprepitant dimeglumine in patients with breakthrough chemotherapy-induced nausea and vomiting (CINV) after failing prophylactic antiemetic therapy.
- 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-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.
|United States, Oregon|
|Knight Cancer Institute at Oregon Health and Science University|
|Portland, Oregon, United States, 97239-3098|
|Principal Investigator:||Joseph Bubalo, PharmD, BCPS, BCOP||OHSU Knight Cancer Institute|