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

• Status: Terminated
• Trial end date: 2017-09-30
• Target enrollment: 0
• Participant gender: All

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

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

Details

• Lead Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aprepitant; Fosaprepitant; Granisetron

Criteria

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