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

NCT01649258 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: 1B-11-5NCI-2012-01170
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; Nausea; Vomiting

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Within the first 24 hours of treatment

• 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)

  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.

  Up to day 4

Study Arms (1)

Supportive care (antiemetics)

EXPERIMENTAL

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; Drug: fosaprepitant dimeglumine; Other: laboratory biomarker analysis

Interventions

granisetron transdermal system DRUG

Given granisetron transdermal system patch

Also known as: granisetron transdermal patch, Sancuso

Supportive care (antiemetics)

fosaprepitant dimeglumine DRUG

Given IV

Supportive care (antiemetics)

laboratory biomarker analysis OTHER

Correlative studies

Supportive care (antiemetics)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Nausea; Vomiting

Interventions

Granisetron; fosaprepitant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Agustin Garcia

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 25, 2012
• Study Start: September 4, 2012
• Primary Completion: May 22, 2017
• Study Completion: September 30, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

US (1)