Trial record 1 of 1 for:    NCT01736917
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Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Germ Cell Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Hoosier Cancer Research Network
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT01736917
First received: November 21, 2012
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Chemotherapy-Induced Nausea and Vomiting
Drug: Fosaprepitant
Drug: Dexamethasone
Drug: 5HT3
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Patients With Germ Cell Tumors Undergoing 5 Day Cisplatin-based Chemotherapy: Hoosier Oncology Group Study QL12-153

Resource links provided by NLM:


Further study details as provided by Hoosier Cancer Research Network:

Primary Outcome Measures:
  • Determine the Complete Response (CR) Rate of No Emetic Episodes or Use of Rescue Medications [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    This will determine the Complete Response (CR) rate (no emetic episodes or use of rescue medications) in germ cell tumor patients treated with IV fosaprepitant in combination with a 5HT3RA plus dexamethasone during a 5 day cisplatin regimen


Secondary Outcome Measures:
  • Measure the Incidence of Vomiting or Retching [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    This will measure the incidence of vomiting or retching via patient log Days 1-8.

  • Describe Detailed Use of Rescue Medications. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    This will describe the detailed use of rescue medications for patients via patient log.

  • Describe the Patient's Self-Reported Assessment of Nausea [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    This will describe the patient's self-reported assessment of nausea Days 1-8 using a 0-100mm visual analog scale (VAS).

  • Determine the Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    This will determine the safety and toxicity of the treatment regimen utilizing CTCAE V4.0


Estimated Enrollment: 64
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone

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: Fosaprepitant
Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophylaxis
Drug: Dexamethasone
Dexamethasone 20mg PO daily on D1 and 2 for acute prophylaxis Dexamethasone 4mg PO BID on Days 6 through 8
Drug: 5HT3
Any 5HT3RA on D1-5; D1, 3 and 5 if palonosetron is used.

Detailed Description:

OUTLINE: This is a multi-center study.

Treatment Regimen:

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). This will usually be combined with bleomycin (BEP), etoposide (EP), ifosfamide (VIP), vinblastine (VeIP), paclitaxel (TIP) or epirubicin. All of these regimens get the identical cisplatin, which is the only highly emetic drug in any of the chemo regimens.

Acute emesis prophylaxis (administered per institutional standards prior to chemotherapy):

  • Any 5HT3 receptor antagonist may be used days 1 through 5 or days 1, 3 and 5 if palonosetron is used per institutional standards.
  • Dexamethasone 20mg PO (orally) daily, days 1 and 2
  • Fosaprepitant 150mg IV on day 3

Delayed emesis prophylaxis:

  • Fosaprepitant 150mg IV on day 5
  • Dexamethasone 4mg PO BID (twice a day) on days 6, 7 and 8

PRN (as needed) 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

ECOG Performance Status of 0-2

Life Expectancy: Not specified

Hematopoietic:

  • White blood cell count (WBC) > 3.0 K/mm3
  • Absolute neutrophil count ≥ 1.5 K/mm3
  • Hemoglobin (Hgb) > 10 g/dL
  • Platelets > 100 K/mm3

Hepatic:

  • Bilirubin < 1.5 x ULN (upper limit of normal)
  • Aspartate aminotransferase (AST, SGOT) ≤ 3 x ULN
  • Alanine aminotransferase (ALT, SGPT) ≤ 3 x ULN

Renal:

  • Creatinine ≤ 2 mg/dl
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  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: NCT01736917

Contacts
Contact: Lawrence Einhorn, M.D. 317.944.3515 leinhorn@iupui.edu
Contact: Cynthia Burkhardt 317.921.2050 gegould@iupui.edu

Locations
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lawrence Einhorn, M.D.    317-274-0920    leinhorn@iupui.edu   
Contact: Kerry Bridges    317-274-2552    kdbridge@iupui.edu   
United States, Missouri
Siteman Cancer Center Recruiting
St. Louis, Missouri, United States, 63110
Contact: Joel Picus, M.D.    314-747-1367      
Contact: Henry Robinson    314-747-1375    hrobinso@im.wustl.edu   
United States, Nebraska
Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68114
Contact: Ralph Hauke, M.D.    402-354-8124      
Contact: Kim Bland, R.N.    402-354-5144    kbland@mnhs.org   
United States, South Carolina
MUSC Hollings Cancer Center Withdrawn
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Hoosier Cancer Research Network
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Lawrence Einhorn, M.D. Hoosier Cancer Research Network
  More Information

Additional Information:
No publications provided

Responsible Party: Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT01736917     History of Changes
Other Study ID Numbers: QL12-153
Study First Received: November 21, 2012
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Hoosier Cancer Research Network:
Fosaprepitant
5HT3 Receptor Antagonists
Dexamethasone
Germ Cell Tumors
Testis Cancer
Rescue Medications

Additional relevant MeSH terms:
Vomiting
Neoplasms, Germ Cell and Embryonal
Signs and Symptoms, Digestive
Signs and Symptoms
Neoplasms by Histologic Type
Neoplasms
Dexamethasone acetate
Dexamethasone
Aprepitant
Dexamethasone 21-phosphate
BB 1101
Serotonin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on July 22, 2014