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

Primary Purpose

Breast Cancer, Nausea, Vomiting

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
granisetron transdermal system
fosaprepitant dimeglumine
laboratory biomarker analysis
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (antiemetics)

Arm Description

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.

Outcomes

Primary Outcome Measures

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)
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.
Proportion of patients with complete response, defined as no emesis and no use of rescue medication in delayed phase (within 2-4 days of treatment)
The complete response rate with the exact 95% 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.

Secondary Outcome Measures

Full Information

First Posted
July 20, 2012
Last Updated
November 15, 2017
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01649258
Brief Title
Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of Efficacy
Study Start Date
September 4, 2012 (Actual)
Primary Completion Date
May 22, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Nausea, Vomiting

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (antiemetics)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
granisetron transdermal system
Other Intervention Name(s)
granisetron transdermal patch, Sancuso
Intervention Description
Given granisetron transdermal system patch
Intervention Type
Drug
Intervention Name(s)
fosaprepitant dimeglumine
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
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)
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.
Time Frame
Within the first 24 hours of treatment
Title
Proportion of patients with complete response, defined as no emesis and no use of rescue medication in delayed phase (within 2-4 days of treatment)
Description
The complete response rate with the exact 95% 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.
Time Frame
Up to day 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agustin Garcia
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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