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

NCT01031953 | Terminated Phase 1 Results DMC

• 3 other identifiers: CDR0000612580P30CA069533OHSU-HEM-08053-L
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

nausea and vomiting; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale

  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.

  Baseline to 2 hours after study drug administered.

Secondary Outcomes (7)

• 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

Study Arms (1)

Fosaprepitant

EXPERIMENTAL

Drug: fosaprepitant dimeglumine; Drug: systemic chemotherapy; Other: survey administration; Procedure: quality-of-life assessment

Interventions

fosaprepitant dimeglumine 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.

Fosaprepitant

systemic chemotherapy 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

Fosaprepitant

survey administration OTHER

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

Fosaprepitant

quality-of-life assessment 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

Fosaprepitant

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Vomiting; Nausea

Interventions

fosaprepitant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Limitations and Caveats

* Missing data did affect results for the 24 hour mark * Lack of control group to measure possible neurokinin-1 antagonist (NK1a) inhibition

Results Point of Contact

• Title: Dr. Joseph Bubalo
• Organization: Oregon Health & Science University

bubaloj@ohsu.edu

503-494-8007

Study Officials

• Joseph Bubalo, PharmD, BCPS, BCOP

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD

Study Record Dates

• First Submitted: December 13, 2009
• First Posted: December 15, 2009
• Study Start: August 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 9, 2017
• Results First Posted: January 30, 2014

Record last verified: 2017-05

Locations

US (1)