NCT01736917

Brief Summary

The hypothesis is that the substitution of multi-day oral aprepitant with (intravenous) IV fosaprepitant, in combination with a 5-HT3 receptor antagonists (5HT3RA) + dexamethasone will provide comparable protection from 5 day cisplatin chemotherapy induced nausea and vomiting, compared to the results of our prior study of aprepitant. This study will be the first clinical trial evaluating fosaprepitant in patients receiving multi-day cisplatin. This will be a single arm, phase II study. The investigators propose to utilize intravenous (IV) fosaprepitant on days 3 and 5 of the 5-day cisplatin chemotherapy regimen. It is anticipated that fosaprepitant can suppress delayed chemo-induced nausea and vomiting for 2-5 days after therapy. This study will test the value of fosaprepitant in this patient population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

4 active sites

Status
completed

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

November 21, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
12 months until next milestone

Results Posted

Study results publicly available

May 25, 2016

Completed
Last Updated

May 25, 2016

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

November 21, 2012

Results QC Date

March 1, 2016

Last Update Submit

April 18, 2016

Conditions

Chemotherapy-Induced Nausea and Vomiting

Keywords

Fosaprepitant5HT3 Receptor AntagonistsDexamethasoneGerm Cell TumorsTestis CancerRescue Medications

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting

    complete response (CR) of both acute (days 1 through 5) and delayed (days 6 through 8) CINV, defined by no emetic episodes or use of rescue medications

    Days 1-8 of chemotherapy regimen

Secondary Outcomes (3)

  • Total Number of Emetic Episodes

    Days 1-8 of chemotherapy regimen

  • Use of Rescue Medications.

    Days 1-8 of chemotherapy regimen

  • Self-Reported Assessment of Nausea

    Days 1-8 of chemotherapy regimen

Study Arms (1)

Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone

EXPERIMENTAL

Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied. * Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days). Acute emesis prophylaxis: * Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards. * Dexamethasone 20mg PO (orally) daily, D1 and 2 * Fosaprepitant 150mg IV on day 3 Delayed emesis prophylaxis: * Fosaprepitant 150mg IV on D5 * Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8 PRN antiemetics allowed at the discretion of the treating investigator * No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods

Drug: FosaprepitantDrug: DexamethasoneDrug: 5HT3

Interventions

FosaprepitantDRUG

Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophylaxis

Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
DexamethasoneDRUG

Dexamethasone 20mg PO daily on D1 and 2 for acute prophylaxis Dexamethasone 4mg PO BID on Days 6 through 8

Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
5HT3DRUG

Any 5HT3RA on D1-5; D1, 3 and 5 if palonosetron is used.

Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone

Eligibility Criteria

Age15 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients ≥15 years of age with histologically or cytologically confirmed diagnosis of germ cell tumor receiving a standard 5 day cisplatin based chemotherapy regimen. Prior chemotherapy is allowed. Patients do not have to be chemo naïve.
  • Written informed consent and HIPAA authorization for release of personal health information.
  • Patients must have had no nausea or vomiting for 24 hours and no anti-emetic use for 72 hours prior to starting protocol therapy. Treatment must not start in registered patients until this criteria is met.

You may not qualify if:

  • No active central nervous system (CNS) metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis. NOTE: A patient with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.
  • No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason \< grade 7 prostate cancers, or other cancer for which the patient has been disease-free for at least 1 year.
  • No previous treatment with any investigational agent within 30 days prior to registration for protocol therapy.
  • No concurrent participation in a clinical trial which involves another investigational agent.
  • No use of agents expected to induce the metabolism of fosaprepitant which include: rifampin, rifabutin, phenytoin, carbamazepine, and barbiturates.
  • No concurrent use of agents which may inhibit metabolism of fosaprepitant which include: cisapride, macrolide antibiotics (erythromycin, clarithromycin, azithromycin), azole antifungal agents (ketoconazole, itraconazole, voriconazole, fluconazole), amifostine, nelfinavir, calcium channel antagonists such as verapamil and diltiazem, and ritonavir.
  • No concurrent use of warfarin while on study.
  • No known history of anticipatory nausea or vomiting.
  • No clinically significant infections as judged by the treating investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68114, United States

Location

MUSC Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Related Publications (3)

  • Costantine Albany, Nasser H. Hanna, Joel Picus, Ralph J. Hauke, Christopher A. Fausel, Ziyue Liu, Mary J. Brames, Lawrence H. Einhorn. Phase II study of fosaprepitant plus 5HT3 receptor antagonists plus dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: Hoosier Oncology Group QL12-153. J Clin Oncol 32:5s, 2014 (suppl; abstr TPS4594)

    BACKGROUND

  • Brames MJ, Case-Eads S, Hanna NH, Fausel CA, Breen T, Einhorn LH. Phase II study of fosaprepitant +5HT3 receptor antagonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: A Hoosier Cancer Research Network Study. J Clin Oncol 33:5s, 2015 (suppl; abstr e20737)

    RESULT

  • Adra N, Albany C, Brames MJ, Case-Eads S, Johnson CS, Liu Z, Fausel CA, Breen T, Hanna NH, Hauke RJ, Picus J, Einhorn LH. Phase II study of fosaprepitant + 5HT3 receptor antagonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: a Hoosier Cancer Research Network study. Support Care Cancer. 2016 Jul;24(7):2837-42. doi: 10.1007/s00520-016-3100-y. Epub 2016 Feb 2.

    PMID: 26838019DERIVED

Related Links

MeSH Terms

Conditions

VomitingNeoplasms, Germ Cell and EmbryonalTesticular Neoplasms

Interventions

fosaprepitantDexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Clinical Data Coordinator
Organization
Hoosier Cancer Research Network, Inc.
jsmith@hoosiercancer.org
317-921-2050

Study Officials

  • Lawrence Einhorn, M.D.

    Hoosier Cancer Research Network

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

November 21, 2012

First Posted

November 29, 2012

Study Start

January 1, 2013

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

May 25, 2016

Results First Posted

May 25, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

US(4)