A Phase 2 interventional study of eribulin mesylate in Head and Neck Cancer, sponsored by National Cancer Institute (NCI). Completed at 139 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-25.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well E7389 works in treating patients with metastatic or recurrent head and neck cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive E7389 IV on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.
This study's enrollment of 42 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN)
Measurable disease
PATIENT CHARACTERISTICS:
No prior malignancies except for the following:
PRIOR CONCURRENT THERAPY:
At least 6 months since prior induction or adjuvant chemotherapy for patients who relapsed after receiving this therapy
eribulin mesylate
Drug: eribulin mesylate
1.4 mg/m2 by IV bolus on Days 1 and 8 of an every 21-day cycle.
Also known as: E7389
Response Probability (Confirmed Complete and Partial Responses)
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
Progression-Free Survival
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.
Overall Survival
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.
Participants With a Given Type of AE
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.
From June 2006 to December, 2007 a total of 42 patients were enrolled from SWOG institutions
| Milestone | Treatment (E7389 IV) |
|---|---|
| Started | 40 |
| Completed | 0 |
| Not completed | 40 |
| Withdrew: Adverse event | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lack of efficacy | 32 |
| Withdrew: Death | 2 |
| Withdrew: Not protocol specified | 1 |
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.
| participants | Treatment (E7389 IV) |
|---|---|
| Complete Response | 0 |
| Partial Response | 2 |
| No Response | 38 |
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.
| months | Treatment (E7389 IV) |
|---|---|
| Progression-Free Survival | 3 (1 to 3) |
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.
| months | Treatment (E7389 IV) |
|---|---|
| Overall Survival | 7 (5 to 10) |
The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.
| participants | Treatment (E7389 IV) |
|---|---|
| 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 |
Collected over Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (E7389 IV) | — | 5/40 (12.5%) | 36/40 (90%) |
| Event | Treatment (E7389 IV) |
|---|---|
| LymphopeniaInvestigations | 2/40 |
| Dry mouth/salivary gland (xerostomia)Gastrointestinal disorders | 1/40 |
| Infection (documented clinically or microbiologically) with Grade3 or 4 neutrophils-Skin(cellulitis)Infections and infestations | 1/40 |
| Leukocytes (total WBC)Investigations | 1/40 |
| Neutrophils/granulocytes (ANC/AGC)Investigations | 1/40 |
| Weight lossInvestigations | 1/40 |
| Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOSRespiratory, thoracic and mediastinal disorders | 1/40 |
| Event | Treatment (E7389 IV) |
|---|---|
| HemoglobinBlood and lymphatic system disorders | 20/40 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 20/40 |
| NauseaGastrointestinal disorders | 14/40 |
| Neutrophils/granulocytes (ANC/AGC)Investigations | 12/40 |
| Hair loss/Alopecia (scalp or body)Skin and subcutaneous tissue disorders | 12/40 |
| Leukocytes (total WBC)Investigations | 11/40 |
| DiarrheaGastrointestinal disorders | 9/40 |
| LymphopeniaInvestigations | 9/40 |
| Weight lossInvestigations | 8/40 |
| Albumin, serum-low (hypoalbuminemia)Metabolism and nutrition disorders | 6/40 |
| Age, Continuous(years) | Treatment (E7389 IV) |
|---|---|
| Median | 61 (44 to 87) |
| Sex: Female, Male(Participants) | Treatment (E7389 IV) |
|---|---|
| Female | 11 |
| Male | 29 |
| Race (NIH/OMB)(Participants) | Treatment (E7389 IV) |
|---|---|
| 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 |
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This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)