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

Purpose

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	Intervention
Breast Cancer Nausea Vomiting	Drug: granisetron transdermal system Drug: fosaprepitant dimeglumine Other: laboratory biomarker analysis


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Nausea and Vomiting

Drug Information available for: Granisetron hydrochloride Granisetron Aprepitant Fosaprepitant Fosaprepitant dimeglumine

U.S. FDA Resources

Further study details as provided by University of Southern California:

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) [ 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.


Enrollment:	29
Actual Study Start Date:	September 4, 2012
Estimated Study Completion Date:	September 4, 2018
Primary Completion Date:	May 22, 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649258

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


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) )
Study First Received:	July 20, 2012
Last Updated:	September 12, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017