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

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aprepitant; Fosaprepitant

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