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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
OBJECTIVES: Evaluate the response probability (confirmed, complete, and partial responses) in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with E7389. Estimate progression-free and overall survival probability in these patients. Evaluate the qualitative and quantitative toxicities of this treatment regimen. 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.

Official Title
-----------------
Phase II Evaluation of E7389 (NSC-707389) in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Drug: eribulin mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) Disease is either metastatic at diagnosis or has persisted, metastasized, or recurred after definitive surgery and/or radiotherapy Not amenable to surgical resection for salvage therapy No newly diagnosed nonmetastatic disease No salivary or nasopharyngeal primary disease Patients who have failed primary surgery alone, and who have disease that is salvageable by radiation or chemoradiation, are not eligible Measurable disease Measurable disease within a previous radiotherapy port must demonstrate clearly progressive disease No active or prior CNS metastasis PATIENT CHARACTERISTICS: Zubrod performance status 0-1 Absolute granulocyte count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Bilirubin ≤ 2 times upper limit of normal (ULN) SGOT and SGPT ≤ 2 times ULN Creatinine ≤ 2 times ULN Not pregnant or nursing Fertile patients must use effective contraception No known HIV positivity No prior malignancies except for the following: Adequately treated basal cell or squamous cell skin cancer In situ cervical cancer Adequately treated stage I or II cancer currently in complete remission Any other cancer for which the patient has been disease free for ≥ 5 years PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior chemotherapy for recurrent or newly diagnosed metastatic disease At least 6 months since prior induction or adjuvant chemotherapy for patients who relapsed after receiving this therapy No more than 1 prior induction or adjuvant regimen (may have included a taxane) More than 2 weeks since prior biologic therapy (i.e., epidermal growth factor inhibitors and vascular endothelial growth factor inhibitors) More than 28 days since prior radiotherapy and recovered More than 28 days since prior surgery and recovered No other concurrent therapy (i.e., radiotherapy, chemotherapy, immunotherapy, biologic therapy, or gene therapy) for SCCHN No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent prophylactic colony-stimulating factors during course 1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eribulin mesylate<br>eribulin mesylate | Drug: eribulin mesylate<br>* 1.4 mg/m2 by IV bolus on Days 1 and 8 of an every 21-day cycle.<br>* Other names: E7389;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Every 6 weeks until progression of disease up to a maximum of 3 years after registration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Every 3 weeks while on protocol therapy, up to 3 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, untreated metastatic squamous neck cancer with occult primary, salivary gland squamous cell carcinoma