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A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer

This study has been completed.
Sponsor:
Collaborators:
Fatima Memorial Hospital
Montefiore Medical Center
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT01744340
First received: February 23, 2012
Last updated: March 11, 2016
Last verified: March 2016
Results First Received: January 12, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Head and Neck Cancer
Colon Cancer
Interventions: Drug: Head and neck
Drug: Colon- Closed as of May 2014

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Head and Neck

Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2

Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter

Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Colon- Closed as of May 2014

Eribulin Mesylate:

1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Colon- Closed as of May 2014: Eribulin Mesylate:

1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle


Participant Flow:   Overall Study
    Head and Neck     Colon- Closed as of May 2014  
STARTED     8     15  
COMPLETED     8     15  
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
Head and Neck

Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2

Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter

Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Colon- Closed as of May 2014

Eribulin Mesylate:

1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Colon- Closed as of May 2014: Eribulin Mesylate:

1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Total Total of all reporting groups

Baseline Measures
    Head and Neck     Colon- Closed as of May 2014     Total  
Number of Participants  
[units: participants]
  8     15     23  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     9     14  
>=65 years     3     6     9  
Age  
[units: years]
Mean (Full Range)
  58.5  
  (45 to 70)  
  71  
  (41 to 86)  
  60.6  
  (41 to 86)  
Gender  
[units: participants]
     
Female     0     8     8  
Male     8     7     15  
Region of Enrollment  
[units: participants]
     
United States     8     15     23  



  Outcome Measures
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1.  Primary:   If Eribulin Mesylate, up to a Maximum Dose of 1.4 mg/m2 Day 1 and 8 of a 21 Day Cycle, Can be Safely Combined With Full Dose Cetuximab for Patients With Advanced Head and Neck Cancer and Colon Cancer.   [ Time Frame: From Day 1 of Drug through end of cycle 2 equals (approximately) 42 days ]

2.  Secondary:   Response Rate (Whether Patient's Disease is Progressing or Being Controlled) of Patients With Head and Neck Cancer Treated With Eribulin Mesylate and Cetuximab.   [ Time Frame: From beginning of treatment to progression of disease, for an expected average of 1 year ]


  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 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: Howard Safran, MD
Organization: BrUOG-Brown University Oncology Research Group
phone: 4018633000
e-mail: kristen_mitchell@brown.edu



Responsible Party: howard safran, Brown University
ClinicalTrials.gov Identifier: NCT01744340     History of Changes
Other Study ID Numbers: BrUOG 254
Study First Received: February 23, 2012
Results First Received: January 12, 2016
Last Updated: March 11, 2016
Health Authority: United States: Food and Drug Administration