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

OHSU Knight Cancer Institute

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Breakthrough Nausea and Vomiting

Treatments

Drug: fosaprepitant dimeglumine

Other: survey administration

Procedure: quality-of-life assessment

Drug: systemic chemotherapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01031953

CDR0000612580

OHSU-HEM-08053-L (Other Identifier)

P30CA069533 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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