Breast Cancer | Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy
Breast Cancer research study
What is the primary objective of this study?
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
Who is eligible to participate?
Inclusion Criteria: - 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 Exclusion Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:granisetron transdermal systemGiven granisetron transdermal system patch
Drug:fosaprepitant dimeglumineGiven IV
Other:laboratory biomarker analysisCorrelative studies
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Supportive care (antiemetics)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 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.
Start Date: September 4, 2012
Completed Date: September 30, 2017
Phase: Phase 1
Primary Outcome: Proportion of patients with complete response, defined as no emesis and no use of rescue medication in acute phase (within first 24 hours of treatment)
Study sponsors, principal investigator, and references
Principal Investigator: Agustin Garcia
Lead Sponsor: University of Southern California
Collaborator: National Cancer Institute (NCI)