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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01736917
First Posted: November 29, 2012
Last Update Posted: May 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hoosier Cancer Research Network
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Lawrence Einhorn, Hoosier Cancer Research Network
Results First Submitted: March 1, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Chemotherapy-Induced Nausea and Vomiting
Interventions: Drug: Fosaprepitant
Drug: Dexamethasone
Drug: 5HT3

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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/m^2 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

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


Participant Flow:   Overall Study
    Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
STARTED   65 
COMPLETED   54 
NOT COMPLETED   11 
Adverse Event                1 
Protocol Violation                10 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
64 participants were consented and treated per protocol. 1 participant listed in participant flow experienced an adverse event during infusion and was immediately taken off study. His baseline characteristics are not included in this table.

Reporting Groups
  Description
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/m^2 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

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


Baseline Measures
   Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone 
Overall Participants Analyzed 
[Units: Participants]
 64 
Age 
[Units: Years]
Median (Full Range)
 33 
 (15 to 66) 
Gender 
[Units: Participants]
 
Female   0 
Male   64 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   3 
Not Hispanic or Latino   61 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   64 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   64 
Eastern Cooperative Oncology Group (ECOG) performance status [1] 
[Units: Participants]
 
ECOG PS 0   59 
ECOG PS 1   4 
ECOG PS 2   1 
[1] Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead:
Cancer Stage [1] 
[Units: Participants]
 
Cancer Stage I   27 
Cancer Stage II   24 
Cancer Stage III   11 
Cancer Stage IS   1 
Cancer Stage Unknown   1 
[1]

Stage 0 Abnormal cells are present but have not spread to nearby tissue. Also called carcinoma in situ, or CIS. CIS is not cancer, but it may become cancer.

Stage I, Stage II, and Stage III Cancer is present. The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues.

Stage IV The cancer has spread to distant parts of the body.

Prior Chemotherapy 
[Units: Participants]
 
Participants with Prior Chemotherapy   5 
Participants without Prior Chemotherapy   59 
Chemotherapy Regimen 
[Units: Participants]
 
Bleomycin, etoposide, cisplatin   51 
Etoposide, cisplatin   10 
Vinblastine, ifosfamide, cisplatin   2 
Cisplatin, Epirubicin   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting   [ Time Frame: Days 1-8 of chemotherapy regimen ]

2.  Secondary:   Total Number of Emetic Episodes   [ Time Frame: Days 1-8 of chemotherapy regimen ]

3.  Secondary:   Use of Rescue Medications.   [ Time Frame: Days 1-8 of chemotherapy regimen ]

4.  Secondary:   Self-Reported Assessment of Nausea   [ Time Frame: Days 1-8 of chemotherapy regimen ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Data Coordinator
Organization: Hoosier Cancer Research Network, Inc.
phone: 317-921-2050
e-mail: jsmith@hoosiercancer.org


Publications:

Responsible Party: Lawrence Einhorn, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT01736917     History of Changes
Other Study ID Numbers: QL12-153
First Submitted: November 21, 2012
First Posted: November 29, 2012
Results First Submitted: March 1, 2016
Results First Posted: May 25, 2016
Last Update Posted: May 25, 2016