Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Southern California
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with histologically confirmed breast cancer scheduled to receive chemotherapy with doxorubicin and cyclophosphamide (adjuvant or neoadjuvant)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Projected life expectancy of at least 3 months
Provision of informed consent prior to any study-related procedures
Negative pregnancy test for women of childbearing potential
Absolute neutrophil count (ANC) \>= 1500/mm\^3
Platelet count \>= 100,000 cells/mm\^3
Hemoglobin \>= 9.0g/dL
Serum creatinine =\< 1.5 mg/dl
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 X upper limit of normal (ULN)
Alkaline phosphatase =\< 2.5 X upper limit of normal; in patients with bone metastasis and no evidence of liver metastasis and bilirubin =\< upper limit of normal an alkaline phosphatase =\< 5 ULN will be allowed
Serum bilirubin =\< 1.0 mg/dL
No other concomitant therapy directed at the cancer is allowed
You may not be if
Allergy or intolerance to 5HT3 or NK-1 antagonists and dexamethasone
Use of another antiemetic agent (5HT3 antagonists, phenothiazines, butyrophenones, cannabinoids, metoclopramide, or corticosteroids) within 72 hours prior to day 1 of the study
Use of anticoagulant agent (Warfarin, Coumadin, Jantoven, Marevan, Lawarin, Waran, or Warfant)
An episode of vomiting or retching within 24 hours before the start of the initial treatment with chemotherapy
Severe concurrent illness other than neoplasia
Gastrointestinal obstruction or an active peptic ulcer
Patients who are pregnant or breast feeding because aprepitant may be harmful to the developing fetus and newborn
Clareo Health | Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy
