Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy
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ClinicalTrials.gov Identifier: NCT01649258 |
Recruitment Status
:
Terminated
(Lack of Efficacy)
First Posted
: July 25, 2012
Last Update Posted
: November 17, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Nausea Vomiting | Drug: granisetron transdermal system Drug: fosaprepitant dimeglumine Other: laboratory biomarker analysis | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
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 |
Actual Study Start Date : | September 4, 2012 |
Actual Primary Completion Date : | May 22, 2017 |
Actual Study Completion Date : | September 30, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Drug: granisetron transdermal system
Given granisetron transdermal system patch
Other Names:
Drug: fosaprepitant dimeglumine
Given IV
Other: laboratory biomarker analysis
Correlative studies
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- 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) [ Time Frame: Within the 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) [ Time Frame: Up to day 4 ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649258
United States, California | |
USC Norris Comprehensive Cancer Center | |
Los Angeles, California, United States, 90033 |
Principal Investigator: | Agustin Garcia | University of Southern California |
Responsible Party: | University of Southern California |
ClinicalTrials.gov Identifier: | NCT01649258 History of Changes |
Other Study ID Numbers: |
1B-11-5 NCI-2012-01170 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
First Posted: | July 25, 2012 Key Record Dates |
Last Update Posted: | November 17, 2017 |
Last Verified: | November 2017 |
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 |
Additional relevant MeSH terms:
Granisetron Breast Neoplasms Nausea Vomiting Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Signs and Symptoms, Digestive Signs and Symptoms Fosaprepitant |
Aprepitant Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurokinin-1 Receptor Antagonists |