Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer

Inclusion Criteria

• Patients must have histologically or cytologically documented salivary gland cancers; patients that do not have a salivary gland primary must have one of the following histologies - adenoid cystic carcinoma, mucoepidermoid carcinoma, acinic cell carcinoma
• Patients must have recurrent and/or metastatic disease that is progressive and not amenable to surgery or curative radiotherapy occurring within 6 months of study entry, as evidenced by: at least a 20% increase in radiographically or clinically measurable disease, appearance of any new lesions, or deterioration in clinical status
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Patients with measurable disease per RECIST 1.1 criteria
• At least one lesion of >= 1.5 cm in long-axis diameter for non lymph nodes or >= 1.5 cm in short-axis diameter for lymph nodes which is serially measurable according to RECIST 1.1 using either computerized tomography (CT) or magnetic resonance imaging (MRI)
• Lesions that have had radiotherapy must show evidence of progressive disease (PD) based on RECIST 1.1 to be deemed a target lesion
• Absolute neutrophil count >= 1,500/μL
• Platelets >= 100,000/μL
• Creatinine clearance >= 40 mL/min
• Bilirubin = 3 x ULN (in the absence of liver metastasis) or > 5 x ULN in subjects with liver metastasis AND the subject is known to have bone metastases, then liver ALP iso-enzyme should be used to assess liver function rather than total ALP
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 12 weeks
• Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment

Exclusion Criteria

• Patients with symptomatic central nervous system (CNS) metastases must have stable disease after treatment with surgery or radiation therapy
• Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
• Radiotherapy within 14 days of study treatment
• Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery
• Treatment with any chemotherapy or investigational agents within 4 weeks of the start of study treatment; subjects must have recovered from toxicities of prior therapy
• Patients with peripheral neuropathy >= grade 2
• Significant cardiovascular impairment: congestive heart failure > class II according to the New York Heart Association (NYHA), unstable angina or myocardial infarction within 6 months of enrollment, or serious cardiac arrhythmia (> grade 2)
• Concomitant severe or uncontrolled medical disease
• Significant psychiatric or neurologic disorder which would compromise participation in the study
• Pregnant or breast-feeding females