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Radiation, Cetuximab and Pemetrexed With or Without Bevacizumab in Locally Advanced Head and Neck Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00703976
First Posted: June 24, 2008
Last Update Posted: April 4, 2017
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.
Collaborators:
Eli Lilly and Company
Genentech, Inc.
Information provided by (Responsible Party):
University of Pittsburgh
Results First Submitted: January 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Cancer
Interventions: Drug: Bevacizumab
Drug: Cetuximab
Drug: Pemetrexed
Radiation: 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
Although 80 patients were enrolled, only 78 began the study because 2 were found to be ineligible prior to treatment.

Reporting Groups
  Description
Cetuximab, Pemetrexed and Radiation Therapy

Cetuximab, Pemetrexed and Radiation therapy

Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.

Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.

Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks

Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab

Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab

Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.

Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.

Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks

Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy.


Participant Flow:   Overall Study
    Cetuximab, Pemetrexed and Radiation Therapy   Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab
STARTED   37   41 
COMPLETED   37   41 
NOT COMPLETED   0   0 



  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
Cetuximab, Pemetrexed and Radiation Therapy

Cetuximab, Pemetrexed and Radiation therapy

Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.

Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.

Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks

Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab

Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab

Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.

Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.

Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks

Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy.

Total Total of all reporting groups

Baseline Measures
   Cetuximab, Pemetrexed and Radiation Therapy   Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   41   78 
Age 
[Units: Years]
Median (Full Range)
 57 
 (39 to 69) 
 56 
 (35 to 76) 
 56 
 (35 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  13.5%      10  24.4%      15  19.2% 
Male      32  86.5%      31  75.6%      63  80.8% 


  Outcome Measures
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1.  Primary:   2-year Progression-free Survival (PFS)   [ Time Frame: 18 months to patient accrual and 2 years of follow-up after closing accrual. ]

2.  Secondary:   2-year Overall Survival (OS)   [ Time Frame: 2 years of follow-up after closing accrual ]


  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
No text entered.


  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: Julie Bauman, MD
Organization: University of Pittsburgh
phone: 412-623-7833
e-mail: baumanje@upmc.edu



Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00703976     History of Changes
Other Study ID Numbers: 07-021
First Submitted: June 20, 2008
First Posted: June 24, 2008
Results First Submitted: January 14, 2016
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017