Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

This study has been completed.
Information provided by (Responsible Party):
Southwest Oncology Group Identifier:
First received: June 13, 2006
Last updated: July 20, 2012
Last verified: July 2012
Results First Received: July 20, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Intervention: Drug: eribulin mesylate

  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
From June 2006 to December, 2007 a total of 42 patients were enrolled from SWOG institutions

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Eligible Patients No text entered.

Participant Flow:   Overall Study
    Eligible Patients  
STARTED     42  
COMPLETED     0 [1]
Ineligible                 2  
Adverse Event                 4  
Withdrawal by Subject                 1  
Lack of Efficacy                 32  
Death                 2  
not protocol specified                 1  
[1] Treatment is not for a fixed period and continues until discontinuation criterion is met.

  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
Eligible Patients No text entered.

Baseline Measures
    Eligible Patients  
Number of Participants  
[units: participants]
[units: years]
Median ( Full Range )
  ( 44 to 87 )  
[units: participants]
Female     11  
Male     29  
Race (NIH/OMB)  
[units: participants]
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     5  
White     33  
More than one race     0  
Unknown or Not Reported     1  

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response Probability (Confirmed Complete and Partial Responses)   [ Time Frame: Every 6 weeks until progression of disease up to a maximum of 3 years after registration ]

2.  Secondary:   Progression-Free Survival   [ Time Frame: Every 6 weeks until progression of disease up to a maximum of 3 years after registration. ]

3.  Secondary:   Overall Survival   [ Time Frame: Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration. ]

4.  Secondary:   Toxicity   [ Time Frame: Every 3 weeks while on protocol therapy ]

  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:  
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: Head and Neck Committtee Statistician
Organization: SWOG Statistical Center
phone: (206)-667-4623

No publications provided

Responsible Party: Southwest Oncology Group Identifier: NCT00337129     History of Changes
Other Study ID Numbers: CDR0000481530, U10CA032102, S0618
Study First Received: June 13, 2006
Results First Received: July 20, 2012
Last Updated: July 20, 2012
Health Authority: United States: Food and Drug Administration