Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00337129
First received: June 13, 2006
Last updated: August 11, 2015
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
2 patients are not eligible before assignment.

Reporting Groups
  Description
Treatment (E7389 IV) Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.

Participant Flow:   Overall Study
    Treatment (E7389 IV)
STARTED   40 
COMPLETED   0 [1] 
NOT COMPLETED   40 
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
  Description
Treatment (E7389 IV) Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.

Baseline Measures
   Treatment (E7389 IV) 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Years]
Median (Full Range)
 61 
 (44 to 87) 
Gender 
[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:   Participants With a Given Type of AE   [ Time Frame: Every 3 weeks while on protocol therapy, up to 3 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:  
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: Head and Neck Committtee Statistician
Organization: SWOG Statistical Center
phone: (206)-667-4623



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00337129     History of Changes
Other Study ID Numbers: NCI-2012-03046
U10CA032102 ( US NIH Grant/Contract Award Number )
S0618 ( Other Identifier: SWOG )
CDR0000481530 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: June 13, 2006
Results First Received: July 20, 2012
Last Updated: August 11, 2015
Health Authority: United States: Food and Drug Administration