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A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00409565
First received: December 7, 2006
Last updated: March 29, 2017
Last verified: March 2017
Results First Received: February 12, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Head and Neck Cancer
Squamous Cell Carcinoma
Interventions: Drug: Cetuximab
Drug: Bevacizumab

  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
We report results in 46 eligible patients. Two patients were deemed ineligible, one because subsequent biopsy showed that measurable disease was actually steoradionecrosis and not recurrent laryngeal cancer. The other patient required surgery for cholecystitis before starting treatment; this patient never initiated protocol treatment.

Reporting Groups
  Description
Cetuximab Plus Bevacizumab

Cetuximab plus bevacizumab

Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY

• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations

Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given


Participant Flow:   Overall Study
    Cetuximab Plus Bevacizumab
STARTED   46 
Overall Response Rate   7 
COMPLETED   45 
NOT COMPLETED   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.
STARTED 46; Overall Response Rate 7; COMPLETED 45; Not Completed 1

Reporting Groups
  Description
Cetuximab Plus Bevacizumab

Cetuximab plus bevacizumab

Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY

• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations

Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given


Baseline Measures
   Cetuximab Plus Bevacizumab 
Overall Participants Analyzed 
[Units: Participants]
 46 
Age 
[Units: Years]
Median (Full Range)
 61.5 
 (33 to 92) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      12  26.1% 
Male      34  73.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      3   6.5% 
Not Hispanic or Latino      43  93.5% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   2.2% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3   6.5% 
White      42  91.3% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   46 
Primary disease site 
[Units: Participants]
 
Oropharynx   17 
Oral cavity   14 
Larynx   7 
Others   8 
Recurrent disease 
[Units: Participants]
 44 
Prior radiation 
[Units: Participants]
 44 
Prior surgery 
[Units: Participants]
 30 
Prior chemotherapy 
[Units: Participants]
 
Prior chemotherapy   42 
1 prior palliative regimen   17 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
 
 11 
 31 
 4 
[1] Eastern Cooperative Oncology Group (ECOG) criteria: 0-Fully active. 1-Ambulatory, carry out work of a light or sedentary nature. 2=Ambulatory, capable of all self care. 3-Capable of limited self care, confined to bed or chair more than 50% of waking hours. 4-Completely disabled, no self care, totally confined to bed or chair. 5-Dead.


  Outcome Measures
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1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: Up to 5 years ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to 5 years ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 5 years ]

4.  Secondary:   Change in Serum Cytokine Concentrations   [ Time Frame: Up to 5 years ]

5.  Secondary:   Disease Control Rate (DCR) ((Clinical Benefit Rate (CBR))   [ Time Frame: At 12 weeks ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael Gibson, MD
Organization: University of Pittsburgh Cancer Institute
phone: 412-692-2600
e-mail: gibsonmk@upmc.edu


Publications of Results:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00409565     History of Changes
Obsolete Identifiers: NCT00407810
Other Study ID Numbers: NCI-2009-00171
NCI / CTEP Protocol # 7440
Study First Received: December 7, 2006
Results First Received: February 12, 2014
Last Updated: March 29, 2017