A Study of a New Combination and Schedule of Chemotherapy Drugs for the Treatment of Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francis (Frank) Worden, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00148122
First received: September 2, 2005
Last updated: March 28, 2014
Last verified: March 2014
Results First Received: February 13, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Interventions: Drug: Docetaxel
Drug: Capecitabine

  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
Docetaxel and Capecitabine

Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)

Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.

Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.


Participant Flow:   Overall Study
    Docetaxel and Capecitabine  
STARTED     40  
COMPLETED     38  
NOT COMPLETED     2  
Withdrawal by Subject                 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.
Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in baseline analysis.

Reporting Groups
  Description
Arm 1

Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)

Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.

Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.


Baseline Measures
    Arm 1  
Number of Participants  
[units: participants]
  38  
Age  
[units: years]
Median ( Full Range )
  59.46  
  ( 39.86 to 75.08 )  
Gender  
[units: participants]
 
Female     6  
Male     32  
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     36  
More than one race     0  
Unknown or Not Reported     2  
Region of Enrollment  
[units: participants]
 
United States     38  
Eastern Cooperative Oncology Group (ECOG) Performance Status [1]
[units: participants]
 
0 (Asymptomatic)     27  
1 (Symptomatic but Completely Ambulatory)     9  
2 (Symtomatic; <50% in Bed During the Day)     2  
Histology  
[units: participants]
 
Squamous Cell Cancer     36  
Adenocarcinoma     1  
Others     1  
Disease Extent  
[units: participants]
 
Local Regional     13  
Distant     17  
Local Regional Distant     7  
Missing     1  
[1] The Eastern Cooperative Oncology Group (ECOG) Performance Status score is an attempt to quantify a cancer patients' general well-being and activities of daily life. It runs from 0 to 5, with 0 denoting perfect health and 5 death



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate at 4 Months   [ Time Frame: 4 months ]

2.  Secondary:   Frequency of Grade III/IV Toxicities Experienced by Participants   [ Time Frame: 30 days post treatment ]

3.  Secondary:   Probability of Progression Free Survival   [ Time Frame: 1 year post treatment ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Dr. Francis Worden
Organization: University of Michigan Comprehensive Cancer Center
phone: 734-936-0453
e-mail: fworden@umich.edu


No publications provided


Responsible Party: Francis (Frank) Worden, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00148122     History of Changes
Other Study ID Numbers: UMCC 2-33, Legacy IRBMED 2002-747
Study First Received: September 2, 2005
Results First Received: February 13, 2014
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board