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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Nausea, Vomiting

Thank you

Trial Information

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


PRIMARY OBJECTIVES:

I. To evaluate the efficacy and safety 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
chemotherapy.

SECONDARY OBJECTIVES:

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.


Inclusion Criteria:



- Patients with histologically confirmed breast cancer scheduled to receive
chemotherapy with doxorubicin and cyclophosphamide (adjuvant or neoadjuvant)

- Southwest Oncology Group (SWOG) 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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)

Outcome Description:

The complete response rate with the exact 95% confidence intervals (CIs) will be calculated. The associations between the complete response rate and patient characteristics and biomarkers will be examined using Fisherâs exact test or Mann-Whitney U test whenever appropriate.

Outcome Time Frame:

Within the first 24 hours of treatment

Safety Issue:

No

Principal Investigator

Agustin Garcia

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

1B-11-5

NCT ID:

NCT01649258

Start Date:

September 2012

Completion Date:

September 2015

Related Keywords:

  • Breast Cancer
  • Nausea
  • Vomiting
  • Breast Neoplasms
  • Nausea
  • Vomiting

Name

Location

USC Norris Comprehensive Cancer CenterLos Angeles, California  90089