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

Completed · Phase 2

Conditions studied: Recurrent Salivary Gland Cancer, Stage IVA Salivary Gland Cancer, Stage IVB Salivary Gland Cancer, Stage IVC Salivary Gland Cancer

In brief

Researchers are doing a research study to examine the use of eribulin (eribulin mesylate) in patients with salivary gland cancer. Researchers want to know if eribulin is safe and effective in treating salivary gland cancer.

Key facts

Study ID: NCT01613768
Run by: University of Washington
People needed: 29
Starts: 2012-05-08
Expected to finish: 2017-08-23
Last updated by the study team: 2018-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 =< 1.5 upper limit of normal (ULN)
Alkaline phosphatase =< 3 ULN; if total ALP is > 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) =< 3 X ULN
Women of child-bearing potential (WOCP) and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation
Life expectancy of > 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

You may not qualify if…

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

Where it is running

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.