Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy
NCT ID: NCT01649258
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
29 participants
INTERVENTIONAL
2012-09-04
2017-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
granisetron transdermal system
Given granisetron transdermal system patch
fosaprepitant dimeglumine
Given IV
laboratory biomarker analysis
Correlative studies
Interventions
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granisetron transdermal system
Given granisetron transdermal system patch
fosaprepitant dimeglumine
Given IV
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Agustin Garcia
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2012-01170
Identifier Type: REGISTRY
Identifier Source: secondary_id
1B-11-5
Identifier Type: -
Identifier Source: org_study_id