S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
This study has been completed.
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00337129
First received: June 13, 2006
Last updated: July 20, 2012
Last verified: July 2012
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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
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
| Description | |
|---|---|
| Eligible Patients | No text entered. |
Participant Flow: Overall Study
| Eligible Patients | |
|---|---|
| STARTED | 42 |
| COMPLETED | 0 [1] |
| NOT COMPLETED | 42 |
| 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
Reporting Groups
| Description | |
|---|---|
| Eligible Patients | No text entered. |
Baseline Measures
| Eligible Patients | |
|---|---|
|
Number of Participants
[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
| 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 ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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. |
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. |
Results Point of Contact:
Name/Title: Head and Neck Committtee Statistician
Organization: SWOG Statistical Center
phone: (206)-667-4623
Organization: SWOG Statistical Center
phone: (206)-667-4623
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov 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 |