NCT02407600

Brief Summary

This study evaluates the addition of fosaprepitant to currently available antiemtic treatments of carboplatin chemotherapy-induced nausea and vomiting in advanced non-small cell lung cancer patients. Half of the patients will receive fosaprepitant in their first chemotherapy cycle, and a placebo on their second chemotherapy cycle. The other half of the patients will begin their first chemotherapy cycle.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

April 3, 2015

Status Verified

March 1, 2015

Enrollment Period

2.8 years

First QC Date

March 20, 2015

Last Update Submit

April 2, 2015

Conditions

Non-small Cell Lung CancerVomitingNauseaEmesis

Keywords

EMEND for Injection5HT-3Fosaprepitant

Outcome Measures

Primary Outcomes (1)

  • Assess the impact of addition of fosaprepitant upon the complete response (C.R.) rate (no emetic episodes or use of rescue medications) in patients with advanced NSCLC receiving carboplatin-based combination chemotherapy.

    The primary end point of the study is to determine the proportion of patients in each of the two groups (placebo and fosaprepitant) who achieve a CR, defined as no vomiting, no retching and no rescue therapy during days 1-5 following the first two cycles of carboplatin based combination chemotherapy using an intent to-treat (ITT) analysis.

    Days 1-5 following the first two cycles of carboplatin based combination chemotherapy

Secondary Outcomes (3)

  • No emesis (defined as no emetic episodes regardless of use of rescue therapy)

    Collection of data at the completion of 2 cycles, day 42.

  • Asses nausea based on visual analog scale (VAS)

    Collection of data at the completion of 2 cycles, day 42.

  • Patient's preferred cycle

    Collection of data at the completion of 2 cycles, day 42.

Study Arms (2)

Fosparepitant administered in 1st cycle

ACTIVE COMPARATOR

Fosaprepitant (Emend) for Injection 150 mg is administered, one time, intravenously on day 1 only, as an infusion with a duration of 30 minutes. It will be initiated approximately 30 minutes prior to the subjects first chemotherapy cycle. An intravenous saline placebo will be administered on day 1 of the second chemotherapy cycle, in the same manor as EMEND for Injection.

Drug: FOSAPREPITANT (Emend)Drug: Placebo

Fosaprepitant administered in 2nd cycle

SHAM COMPARATOR

Subject will receive a saline Placebo intravenously on day 1 of their first chemotherapy cycle. For the subject's second chemotherapy cycle, EMEND for Injection 150 mg is administered, one time, intravenously on day 1, as an infusion with a duration of 30 minutes. It will be initiated approximately 30 minutes prior to the subjects second chemotherapy cycle.

Drug: FOSAPREPITANT (Emend)Drug: Placebo

Interventions

FOSAPREPITANT (Emend)DRUG

Uee of fosprepitant in EITHER first OR 2nd cycle of carboplatin containing combination chemotherapy in patients with advanced NSCLC

Also known as: EMEND for Injection
Fosaprepitant administered in 2nd cycleFosparepitant administered in 1st cycle
PlaceboDRUG
Fosaprepitant administered in 2nd cycleFosparepitant administered in 1st cycle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient age \> 18 years and able to sign informed consent.
  • ECOG PS 0-2
  • Patients with stage IV or recurrent NSCLC being treated with carboplatin based regimen with palliative intent.
  • Acceptable chemotherapy regimens include:
  • Carboplatin (AUC of 5 OR 6) q 21 days with:
  • Paclitaxel Q 21 days OR
  • Docetaxel Q 21 days OR
  • Pemetrexed Q 21 days (non-squamous histology with Vitamin B12 and folate supplementation) OR
  • Gemcitabine administered days 1 and 8 Q 21 days OR
  • Vinorelbine administered days 1 and 8 Q 21 days
  • The addition of bevacizumab to chemotherapy is permitted where indicated and clinically appropriate.
  • Patients who have received prior adjuvant chemotherapy for lung cancer ( \> 1 year prior) and have recurred are eligible if it has been \> 1 year since completion of adjuvant chemotherapy.
  • Patients who have received prior adjuvant chemotherapy for lung cancer ( \> 1 year prior) and have recurred are eligible if it has been \> 1 year since completion of adjuvant chemotherapy.
  • Laboratory parameters:
  • Serum creatinine \< 2.0 and
  • +4 more criteria

You may not qualify if:

  • History of allergic reaction to aprepitant or fosaprepitant
  • Use of other investigational agents concurrently with chemotherapy
  • Uncontrolled systemic hypertension with SBP \> 180 and/ or DBP\> 110
  • Concurrent use of pimozide, terfenadine, astemizole, or cisapride (fosaprepitatnt is a dose-dependent inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4). If used concurrently with above agents, there can be elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions. Patients may be enrolled on the study if at least 7 days have elapsed since last dose of such a medication.
  • Women who are pregnant or lactating are not eligible. Women of childbearing age musthave a negative pregnancy test within 3 days of treatment and agree to use of contraception during the study period.
  • Use of any of the CYP450 inducers like phenytoin, carbamazepine, barbiturates, rifimapicin, rifabutin or St John's wort within 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Related Publications (4)

  • Fernandez-Ortega P, Caloto MT, Chirveches E, Marquilles R, Francisco JS, Quesada A, Suarez C, Zorrilla I, Gomez J, Zabaleta P, Nocea G, Llombart-Cussac A. Chemotherapy-induced nausea and vomiting in clinical practice: impact on patients' quality of life. Support Care Cancer. 2012 Dec;20(12):3141-8. doi: 10.1007/s00520-012-1448-1. Epub 2012 Mar 31.

    PMID: 22460057BACKGROUND

  • Wheatley-Price P, Le Maitre A, Ding K, Leighl N, Hirsh V, Seymour L, Bezjak A, Shepherd FA; NCIC Clinical Trials Group. The influence of sex on efficacy, adverse events, quality of life, and delivery of treatment in National Cancer Institute of Canada Clinical Trials Group non-small cell lung cancer chemotherapy trials. J Thorac Oncol. 2010 May;5(5):640-8. doi: 10.1097/JTO.0b013e3181d40a1b.

    PMID: 20354457BACKGROUND

  • Hesketh PJ, Kris MG, Grunberg SM, Beck T, Hainsworth JD, Harker G, Aapro MS, Gandara D, Lindley CM. Proposal for classifying the acute emetogenicity of cancer chemotherapy. J Clin Oncol. 1997 Jan;15(1):103-9. doi: 10.1200/JCO.1997.15.1.103.

    PMID: 8996130BACKGROUND

  • Grunberg SM, Warr D, Gralla RJ, Rapoport BL, Hesketh PJ, Jordan K, Espersen BT. Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity--state of the art. Support Care Cancer. 2011 Mar;19 Suppl 1:S43-7. doi: 10.1007/s00520-010-1003-x. Epub 2010 Oct 24.

    PMID: 20972805BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungVomitingNausea

Interventions

fosaprepitantAprepitant

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ajeet Gajra, MD FACP

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajeet Gajra, MD FACP

CONTACT

(315) 464-5934gajraa@upstate.edu

Kristine M Garcia, BS

CONTACT

(315) 464-5934garciakr@upstate.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 20, 2015

First Posted

April 3, 2015

Study Start

April 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

April 3, 2015

Record last verified: 2015-03

Locations

US(1)