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A Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in HNSCC (Dasatinib)

This study has been terminated.
(Low accrual)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00882583
First received: April 15, 2009
Last updated: January 4, 2017
Last verified: January 2017
Results First Received: January 4, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Interventions: Drug: Cetuximab
Drug: Dasatinib
Drug: Cisplatin
Radiation: Radiation Therapy

  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
Cohort A T2N0, T1-2N1 SCCHN

In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.

Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).

Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8

Dasatinib: Oral Dasatinib Days 8 through 64.

Radiation Therapy: Standard Radiation Therapy.

Cohort B T3N0-1,T1-4N2-3M0, T4N0-1M0 SCCHN

In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.

Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma (SCC) of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.

Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8

Dasatinib: Oral Dasatinib Days 8 through 64.

Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days

Radiation Therapy: Standard Radiation Therapy.


Participant Flow:   Overall Study
    Cohort A T2N0, T1-2N1 SCCHN   Cohort B T3N0-1,T1-4N2-3M0, T4N0-1M0 SCCHN
STARTED   7   12 
COMPLETED   6   11 
NOT COMPLETED   1   1 
Physician Decision                1                0 
Adverse Event                0                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.
No text entered.

Reporting Groups
  Description
Cohort A

In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.

Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).

Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8

Dasatinib: Oral Dasatinib Days 8 through 64.

Radiation Therapy: Standard Radiation Therapy.

Cohort B

In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.

Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.

Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8

Dasatinib: Oral Dasatinib Days 8 through 64.

Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days

Radiation Therapy: Standard Radiation Therapy.

Total Total of all reporting groups

Baseline Measures
   Cohort A   Cohort B   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   12   19 
Age [1] 
[Units: Years]
Median (Full Range)
 65 
 (60 to 70) 
 58 
 (48 to 68) 
 59 
 (48 to 70) 
[1] Age in years collected at screening
Gender 
[Units: Participants]
Count of Participants
     
Female      3  42.9%      3  25.0%      6  31.6% 
Male      4  57.1%      9  75.0%      13  68.4% 
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%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2  28.6%      2  16.7%      4  21.1% 
White      5  71.4%      10  83.3%      15  78.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   7   12   19 


  Outcome Measures

1.  Primary:   1.Maximally Tolerated Dose (MTD) of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B   [ Time Frame: Last day of Radiation ]

2.  Primary:   Phase I is Efficacy and Safety. Phase II Will be Tumor Response   [ Time Frame: Phase I will enroll over 12-18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
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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.


Results Point of Contact:  
Name/Title: Shanthi Marur
Organization: FDA
phone: 2404026373
e-mail: shanthi.marur@fda.hhs.gov



Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00882583     History of Changes
Other Study ID Numbers: J08101
CA180123 ( Other Grant/Funding Number: BMS )
Study First Received: April 15, 2009
Results First Received: January 4, 2017
Last Updated: January 4, 2017