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

Sponsor

University of Southern California (Other)

Overall Status

Terminated

CT.gov ID

NCT01649258

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

60.8

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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

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:

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:

To evaluate the safety of the combination of fosaprepitant and granisetron transdermal system in breast cancer patients undergoing adjuvan or neoadjuvant chemotherapy.

EXPLORATORY OBJECTIVE:

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

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

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 :

Sep 4, 2012

Actual Primary Completion Date :

May 22, 2017

Actual Study Completion Date :

Sep 30, 2017

Arms and Interventions

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

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

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) [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) [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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