Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer (NCT01613768) | Clinical Trial Compass
CompletedPhase 2
Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer
United States29 participantsStarted 2012-05-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 =\< 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, th…
What they're measuring
1
Response Rate
Timeframe: From date of first study therapy until date of first documented disease progression or date of death from any cause, unacceptable toxicity or withdrawal of patient consent, whichever occurred first, assessed up to 36 days post last dose of study therapy.