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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Nausea; Vomiting	Drug: granisetron transdermal system; Drug: fosaprepitant dimeglumine; Other: laboratory biomarker analysis	Phase 1

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.

Study Design

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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

Arms and Interventions

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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.

Drug: granisetron transdermal system; Given granisetron transdermal system patch; Other Names: granisetron transdermal patch; Sancuso Drug: fosaprepitant dimeglumine; Given IV Other: laboratory biomarker analysis; Correlative studies

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

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

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

Contacts and Locations

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Locations

United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033

Sponsors and Collaborators

University of Southern California

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Agustin Garcia	University of Southern California

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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