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Salivary Gland Cancer

Eribulin for Locally Advanced Salivary Gland Cancers (7674)
Phase II Trial of Eribulin for Locally Advanced Refractory or Metastatic Salivary Gland Cancers
Status Conditions Phase Study ID
Recruiting Salivary Gland Cancer Phase II 7674
NCT01613768
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.


Investigator
Keith D. Eaton, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Patients must have histologically or cytologically documented salivary gland cancers
  • 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 =< 1.5 upper limit of normal (ULN)
  • Total bilirubin =< 1.5 ULN
  • Alkaline phosphatase =< 2.5 ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 X institutional upper limit of normal, unless due to liver metastases (5 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
Exclusions (conditions that would prevent participation in this study)
  • Patients with known 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
Last Updated
November 29, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.