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Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer

This study has been terminated.
(Low accrual)
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00891904
First received: April 30, 2009
Last updated: January 29, 2014
Last verified: January 2014
Results First Received: January 29, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Interventions: Biological: cetuximab
Radiation: stereotactic body radiation therapy

  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
Biological/Vaccine: Cetuximab

All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.

250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2).


Participant Flow:   Overall Study
    Biological/Vaccine: Cetuximab  
STARTED     2  
COMPLETED     0  
NOT COMPLETED     2  
Death                 1  
Adverse Event                 1  



  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.
All treated and eligible patients

Reporting Groups
  Description
Biological/Vaccine: Cetuximab

All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.

250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2).


Baseline Measures
    Biological/Vaccine: Cetuximab  
Number of Participants  
[units: participants]
  2  
Age  
[units: years]
Mean ± Standard Deviation
  67  ± 2.8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     2  
Gender  
[units: participants]
 
Female     0  
Male     2  



  Outcome Measures
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1.  Primary:   Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30   [ Time Frame: Daily while on Treatment ]

2.  Secondary:   Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients   [ Time Frame: 2 years ]

3.  Secondary:   Local and Distant Control   [ Time Frame: every 2 months for year one, every 3-4 months for year 2, every 6 months for ]

4.  Secondary:   Overall Survival   [ Time Frame: every 2 months for year one, every 3-4 months for year 2, every 6 months for ]


  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
Trial terminated early. Too few patients to analyze.


  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: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300


No publications provided


Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00891904     History of Changes
Other Study ID Numbers: CDR0000640992, RPCI-I-143108
Study First Received: April 30, 2009
Results First Received: January 29, 2014
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration