ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide

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.
ClinicalTrials.gov Identifier: NCT01537029
Recruitment Status : Completed
First Posted : February 22, 2012
Results First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions: Breast Cancer
Obesity
Interventions: Drug: Doxorubicin
Drug: Cyclophosphamide

  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
Doxorubicin and Cyclophosphamide

Doxorubicin: Dosed by the patient's treating physician according to local standard of care.

Cyclophosphamide: dosage form: IV, Dosage, frequency, and duration: According to local standard of care


Participant Flow:   Overall Study
    Doxorubicin and Cyclophosphamide
STARTED   15 
COMPLETED   15 
NOT COMPLETED   0 



  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.
No text entered.

Reporting Groups
  Description
Doxorubicin and Cyclophosphamide

Doxorubicin: Dosed by the patient's treating physician according to local standard of care.

Cyclophosphamide: dosage form: IV, Dosage, frequency, and duration: According to local standard of care


Baseline Measures
   Doxorubicin and Cyclophosphamide 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      14  93.3% 
>=65 years      1   6.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   6.7% 
Not Hispanic or Latino      14  93.3% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      6  40.0% 
White      9  60.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures

1.  Primary:   Clearance (Cl) for Doxorubicin and Cyclophosphamide   [ Time Frame: 0-48 hours ]


  Serious Adverse Events


  Other Adverse Events


  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

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: Ronald Hall
Organization: TTUHSC
phone: 2143589009
e-mail: ronald.hall@ttuhsc.edu



Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01537029     History of Changes
Other Study ID Numbers: A11-3691
First Submitted: February 16, 2012
First Posted: February 22, 2012
Results First Submitted: July 24, 2018
Results First Posted: August 22, 2018
Last Update Posted: August 22, 2018