Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck

This study has been terminated.
(slow accrual)
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Emory University
University of North Carolina, Chapel Hill
Genentech, Inc.
OSI Pharmaceuticals
Information provided by (Responsible Party):
Lori J. Wirth, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00392665
First received: October 24, 2006
Last updated: March 15, 2017
Last verified: March 2017
Results First Received: January 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Interventions: Drug: Bevacizumab
Drug: erlotinib
Drug: Sulindac

  Participant Flow
  Hide Participant Flow

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
Erlotinib + Bevacizumab

erlotinib plus bevacizumab

Bevacizumab: Given intravenously on day one of each 3 week cycle

erlotinib: Given orally once a day

Erlotinib + Sulindac

erlotinib plus sulindac

erlotinib: Given orally once a day

Sulindac: Given orally twice a day


Participant Flow:   Overall Study
    Erlotinib + Bevacizumab   Erlotinib + Sulindac
STARTED   18   18 
COMPLETED   1   3 
NOT COMPLETED   17   15 
Death                16                14 
Lost to Follow-up                1                1 



  Baseline Characteristics
  Hide Baseline Characteristics

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
Erlotinib + Bevacizumab

erlotinib plus bevacizumab

Bevacizumab: Given intravenously on day one of each 3 week cycle

erlotinib: Given orally once a day

Erlotinib + Sulindac

erlotinib plus sulindac

erlotinib: Given orally once a day

Sulindac: Given orally twice a day

Total Total of all reporting groups

Baseline Measures
   Erlotinib + Bevacizumab   Erlotinib + Sulindac   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   18   36 
Age 
[Units: Years]
Median (Full Range)
 57 
 (37 to 74) 
 57 
 (37 to 84) 
 57 
 (37 to 84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  16.7%      2  11.1%      5  13.9% 
Male      15  83.3%      16  88.9%      31  86.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      18 100.0%      17  94.4%      35  97.2% 
Unknown or Not Reported      0   0.0%      1   5.6%      1   2.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   5.6%      1   2.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   5.6%      4  22.2%      5  13.9% 
White      17  94.4%      11  61.1%      28  77.8% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      2  11.1%      2   5.6% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   18   18   36 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Efficacy of Erlotinib Plus Bevacizumab (Arm A) or Erlotinib Plus Sulindac (Arm B) as Measured by Progression-free Survival.   [ Time Frame: 1 year ]

2.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: 2 years ]

3.  Secondary:   Duration of Overall Survival   [ Time Frame: 2 years ]

4.  Secondary:   Number of Participants With Toxicities According to Severity   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lori J. Wirth, MD
Organization: Massachusetts General Hospital
phone: 617-724-4000
e-mail: LWIRTH@mgh.harvard.edu



Responsible Party: Lori J. Wirth, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00392665     History of Changes
Other Study ID Numbers: 06-111
Study First Received: October 24, 2006
Results First Received: January 24, 2017
Last Updated: March 15, 2017