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Combination of Taxotere and Oxaliplatin in Squamous Cell Carcinoma of the Head and Neck

This study has been terminated.
(Insufficient Accrual)
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00184028
First received: September 12, 2005
Last updated: May 20, 2014
Last verified: May 2014
Results First Received: March 21, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma of the Head and Neck
Interventions: Drug: Taxotere
Drug: Oxaliplatin

  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
Participants were recruited at USC/Los Angeles County General Hospital and the USC/Norris Cancer Hopital between March 2005 and October 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial had no pre-assignment criteria. All subjects were given the same treatment.

Reporting Groups
  Description
Taxotere Followed by Oxaliplatin On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.

Participant Flow:   Overall Study
    Taxotere Followed by Oxaliplatin  
STARTED     12  
COMPLETED     2  
NOT COMPLETED     10  
Death                 1  
Lack of Efficacy                 4  
Adverse Event                 2  
Withdrawal by Subject                 1  
Non-compliance                 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.
No text entered.

Reporting Groups
  Description
Taxotere Followed by Oxaliplatin On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.

Baseline Measures
    Taxotere Followed by Oxaliplatin  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     2  
Gender  
[units: participants]
 
Female     3  
Male     9  
Ethnicity (NIH/OMB)  
[units: Participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     10  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: Participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     6  
More than one race     0  
Unknown or Not Reported     2  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures
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1.  Primary:   Tumor Response   [ Time Frame: 6 months after the last subject enrolled has gone off study ]

2.  Secondary:   Number of Participants With Serious Adverse Events (SAEs)   [ Time Frame: At end of every cycle ]


  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
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  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: Barbara Gitlitz, MD
Organization: USC/Norris Comrpehensive Cancer Center
phone: 323-865-3906
e-mail: Gitlitz@usc.edu


No publications provided


Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00184028     History of Changes
Other Study ID Numbers: 7H-03-1
Study First Received: September 12, 2005
Results First Received: March 21, 2013
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board