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Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00293384
First Posted: February 17, 2006
Last Update Posted: March 15, 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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Muneer Abidi, Barbara Ann Karmanos Cancer Institute
Results First Submitted: May 12, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Chronic Myeloproliferative Disorders
Gestational Trophoblastic Tumor
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Nausea and Vomiting
Neuroblastoma
Ovarian Cancer
Testicular Germ Cell Tumor
Interventions: Drug: Aprepitant
Drug: Cyclophosphamide
Drug: Dexamethasone
Drug: Granisetron hydrochloride

  Participant Flow
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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
Aprepitant, Dexamethasone, Cytoxan & Kytril

Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.

Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.

Days 2 & 3: Aprepitant 80 mg once daily in the morning.

Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3

Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes

Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.

Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.


Participant Flow:   Overall Study
    Aprepitant, Dexamethasone, Cytoxan & Kytril
STARTED   40 
COMPLETED   35 
NOT COMPLETED   5 
Non-compliance                2 
Missed dosage/study drug                1 
Ineligible                2 



  Baseline Characteristics
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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.
Patients who received all doses of the study drug were considered evaluable patients.

Reporting Groups
  Description
Aprepitant, Dexamethasone, Cytoxan & Kytril

Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.

Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.

Days 2 & 3: Aprepitant 80 mg once daily in the morning.

Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3

Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes

Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.

Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.


Baseline Measures
   Aprepitant, Dexamethasone, Cytoxan & Kytril 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   40 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   17 
Male   23 
Region of Enrollment 
[Units: Participants]
 
United States   40 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Participants With Controlled Acute Vomiting   [ Time Frame: at 0-24 hours ]

2.  Secondary:   Delayed Vomiting Controlled   [ Time Frame: at 25-120 hours ]

3.  Secondary:   Toxicity Grade 3, 4, or 5   [ Time Frame: at 0-120 hours ]

4.  Other Pre-specified:   Overall Nausea Controlled   [ Time Frame: at 0-120 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
There were no other significant limitations except for the details provided.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Muneer Abidi, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
phone: (313) 576-8713
e-mail: abidim@karmanos.org



Responsible Party: Muneer Abidi, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00293384     History of Changes
Other Study ID Numbers: CDR0000456201
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-D-2797 ( Other Identifier: Karmanos Cancer Institute )
WSU-0504001728 ( Other Identifier: Wayne State University - Human Investigation Committee )
First Submitted: February 16, 2006
First Posted: February 17, 2006
Results First Submitted: May 12, 2014
Results First Posted: October 3, 2014
Last Update Posted: March 15, 2016



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