NCT01649258

Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy

A Pilot Study to Evaluate the Efficacy of Fosaprepitant and Granisetron Transdermal System for the Prevention of Acute and Delayed Nausea and Vomiting in Breast Cancer Patients and to Identify Predictors of Response

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies how well fosaprepitant dimeglumine and granisetron transdermal system work in preventing nausea and vomiting in patients with breast cancer undergoing chemotherapy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the efficacy of the combination of fosaprepitant (fosaprepitant dimeglumine) and granisetron transdermal system in the prevention of acute and delayed chemotherapy induced nausea and vomiting in breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy. SECONDARY OBJECTIVE: I. To evaluate the safety of the combination of fosaprepitant and granisetron transdermal system in breast cancer patients undergoing adjuvan or neoadjuvant chemotherapy. EXPLORATORY OBJECTIVE: I. To explore the use of single nucleotide polymorphisms (SNPs) in the 5âhydroxytryptamine-3 (5HT3) and neurokinin-1 (NK-1) receptors as potential markers of efficacy. OUTLINE: Patients receive granisetron transdermal system patch 24-48 hrs before the initiation of chemotherapy. Patients wear the granisetron transdermal system patch for 7 days. Patients receive fosaprepitant dimeglumine intravenously (IV) over 15 minutes on day 1 of chemotherapy. Treatment repeats every 2 or 3 weeks for up to 4 courses in the absence of unacceptable toxicity.

Conditions

• Breast Cancer
• Nausea
• Vomiting

Interventions

Type	Name	Description
DRUG	granisetron transdermal system	Given granisetron transdermal system patch
DRUG	fosaprepitant dimeglumine	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2012-09-04
• Primary completion: 2017-05-22
• Completion: 2017-09-30
• First posted: 2012-07-25
• Last updated: 2017-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study