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

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ClinicalTrials.gov Identifier: NCT00337129
Recruitment Status : Completed
First Posted : June 15, 2006
Results First Posted : August 29, 2012
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head and Neck Cancer
Intervention Drug: eribulin mesylate
Enrollment 42
Recruitment Details From June 2006 to December, 2007 a total of 42 patients were enrolled from SWOG institutions
Pre-assignment Details 2 patients are not eligible before assignment.
Arm/Group Title Treatment (E7389 IV)
Hide Arm/Group Description Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
Period Title: Overall Study
Started 40
Completed 0 [1]
Not Completed 40
Reason Not Completed
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.
Arm/Group Title Treatment (E7389 IV)
Hide Arm/Group Description Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
61
(44 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
11
  27.5%
Male
29
  72.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  12.5%
White
33
  82.5%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.5%
1.Primary Outcome
Title Response Probability (Confirmed Complete and Partial Responses)
Hide Description Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.
Time Frame Every 6 weeks until progression of disease up to a maximum of 3 years after registration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only eligible patients were included in the analysis
Arm/Group Title Treatment (E7389 IV)
Hide Arm/Group Description:
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
Complete Response 0
Partial Response 2
No Response 38
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (E7389 IV)
Comments Null hypothesis: response probability < 5%; alternative hypothesis: response probability > 20%. A two-stage design was used. If no responses among the first 20 patients, the study would be terminated with the conclusion that E7389 is inactive. However, if at least one response was seen then an additional 20 patients would be accrued. Five or more responses out of 40 would be considered evidence that E7389 warranted further study. This design had a significance level of 5% and a power of 92%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method two-stage binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Response probability
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
0.01 to 0.17
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-Free Survival
Hide Description Progression-free survival was defined as the time from date of registration to the date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at date of last contact.
Time Frame Every 6 weeks until progression of disease up to a maximum of 3 years after registration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (E7389 IV)
Hide Arm/Group Description:
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
Overall Number of Participants Analyzed 40
Median (95% Confidence Interval)
Unit of Measure: months
3
(1 to 3)
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from the date of registration to the date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only eligible patients were included in the analysis.
Arm/Group Title Treatment (E7389 IV)
Hide Arm/Group Description:
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
Overall Number of Participants Analyzed 40
Median (95% Confidence Interval)
Unit of Measure: months
7
(5 to 10)
4.Secondary Outcome
Title Participants With a Given Type of AE
Hide Description The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.
Time Frame Every 3 weeks while on protocol therapy, up to 3 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started protocol treatment are included in analysis of toxicity
Arm/Group Title Treatment (E7389 IV)
Hide Arm/Group Description:
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
Dehydration 1
Diarrhea 2
Dry mouth/salivary gland (xerostomia) 1
Dyspnea (shortness of breath) 2
Fatigue (asthenia, lethargy, malaise) 2
Glucose, serum-high (hyperglycemia) 1
Hemoglobin 1
Hemorrhage - Bronchopulmonary NOS 1
Infection w/ Grade 3/4 ANC - Skin (cellulitis) 1
Infection w unk ANC - gums (gingivitis) 1
Leukocytes (total WBC) 5
Lymphopenia 6
Mucositis - gums (gingivitis) 1
Neuropathy: sensory 1
Neutrophils/granulocytes (ANC/AGC) 4
Pneumonitis/pulmonary infiltrates 1
Potassium, serum-low (hypokalemia) 1
Sodium, serum-low (hyponatremia) 2
Time Frame Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
Adverse Event Reporting Description This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
 
Arm/Group Title Treatment (E7389 IV)
Hide Arm/Group Description Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle. Includes only patients who received drug.
All-Cause Mortality
Treatment (E7389 IV)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (E7389 IV)
Affected / at Risk (%)
Total   5/40 (12.50%) 
Gastrointestinal disorders   
Dry mouth/salivary gland (xerostomia)  1  1/40 (2.50%) 
Infections and infestations   
Infection (documented clinically or microbiologically) with Grade3 or 4 neutrophils-Skin(cellulitis)  1  1/40 (2.50%) 
Investigations   
Leukocytes (total WBC)  1  1/40 (2.50%) 
Lymphopenia  1  2/40 (5.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  1/40 (2.50%) 
Weight loss  1  1/40 (2.50%) 
Respiratory, thoracic and mediastinal disorders   
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS  1  1/40 (2.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (E7389 IV)
Affected / at Risk (%)
Total   36/40 (90.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  20/40 (50.00%) 
Gastrointestinal disorders   
Constipation  1  5/40 (12.50%) 
Diarrhea  1  9/40 (22.50%) 
Heartburn/dyspepsia  1  2/40 (5.00%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  4/40 (10.00%) 
Mucositis/stomatitis (functional/symptomatic) - Oral cavity  1  2/40 (5.00%) 
Nausea  1  14/40 (35.00%) 
Pain - Oral cavity  1  2/40 (5.00%) 
Vomiting  1  4/40 (10.00%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  20/40 (50.00%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)  1  2/40 (5.00%) 
Infections and infestations   
Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis)  1  2/40 (5.00%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  2/40 (5.00%) 
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  4/40 (10.00%) 
Alkaline phosphatase  1  5/40 (12.50%) 
Leukocytes (total WBC)  1  11/40 (27.50%) 
Lymphopenia  1  9/40 (22.50%) 
Neutrophils/granulocytes (ANC/AGC)  1  12/40 (30.00%) 
Platelets  1  2/40 (5.00%) 
Weight loss  1  8/40 (20.00%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  1  6/40 (15.00%) 
Anorexia  1  4/40 (10.00%) 
Calcium, serum-low (hypocalcemia)  1  4/40 (10.00%) 
Dehydration  1  3/40 (7.50%) 
Glucose, serum-high (hyperglycemia)  1  6/40 (15.00%) 
Potassium, serum-high (hyperkalemia)  1  2/40 (5.00%) 
Potassium, serum-low (hypokalemia)  1  4/40 (10.00%) 
Sodium, serum-low (hyponatremia)  1  4/40 (10.00%) 
Musculoskeletal and connective tissue disorders   
Pain - Muscle  1  2/40 (5.00%) 
Nervous system disorders   
Neuropathy: sensory  1  5/40 (12.50%) 
Pain - Head/headache  1  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/40 (5.00%) 
Dyspnea (shortness of breath)  1  3/40 (7.50%) 
Skin and subcutaneous tissue disorders   
Hair loss/Alopecia (scalp or body)  1  12/40 (30.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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.
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 ( U.S. NIH Grant/Contract )
S0618 ( Other Identifier: SWOG )
CDR0000481530 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: June 13, 2006
First Posted: June 15, 2006
Results First Submitted: July 20, 2012
Results First Posted: August 29, 2012
Last Update Posted: August 25, 2015