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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase II Trial of Eribulin for Locally Advanced Refractory or Metastatic Salivary Gland Cancers

Brief 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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Evaluate the response rate of eribulin per Response Evaluation Criteria In Solid Tumors (RECIST) in patients with locally advanced refractory or metastatic salivary gland cancer (SGC).

SECONDARY OBJECTIVES:

I. Determine the safety and toxicity of eribulin in patients with locally advanced refractory or metastatic SGC.

II. Evaluate the duration of response and time-to-progression.

TERTIARY OBJECTIVES:

I. Evaluate overall survival.

OUTLINE:

Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.


Sponsor: University of Washington

Current Primary Outcome: Overall response rate, including both complete and partial responses, as defined by RECIST 1.1 criteria [ Time Frame: Up to 30 days after completion of study treatment ]

Summarized using frequencies and percentages.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of response [ Time Frame: Date of the first objective assessment of partial response (PR) or complete response (CR) to the first date of disease relapse or death from any cause, assessed up to 30 days after completion of study treatment ]
    Will be reported as median values.
  • Time to progression [ Time Frame: Date of enrollment to the first date of radiographic progression of disease per RECIST 1.1 criteria, assessed up to 30 days after completion of study treatment ]
    Will be reported as median values.
  • Disease control rate (DCR), defined as stable disease + partial response rate [ Time Frame: Up to 30 days after completion of study treatment ]
    Summarized using frequencies and percentages.
  • Toxicity rates described as the overall percentage of patients experiencing grade 3 or higher toxicity, graded by National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ]
    Summarized using frequencies and percentages.


Original Secondary Outcome: Same as current

Information By: University of Washington

Dates:
Date Received: June 5, 2012
Date Started: May 8, 2012
Date Completion: September 1, 2017
Last Updated: February 17, 2017
Last Verified: February 2017