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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01613768
First received: June 5, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Recurrent Salivary Gland Cancer
Stage IVA Salivary Gland Cancer
Stage IVB Salivary Gland Cancer
Stage IVC Salivary Gland Cancer
Drug: eribulin mesylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Eribulin for Locally Advanced Refractory or Metastatic Salivary Gland Cancers

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Summarized using frequencies and percentages.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Summarized using frequencies and percentages.


Estimated Enrollment: 29
Study Start Date: May 2012
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (eribulin mesylate)
Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: eribulin mesylate
Given IV
Other Names:
  • B1939
  • E7389
  • ER-086526
  • halichrondrin B analog

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613768

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Renato G. Martins    800-804-8824      
Principal Investigator: Renato G. Martins         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Renato Martins Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01613768     History of Changes
Other Study ID Numbers: 7674, NCI-2012-00892
Study First Received: June 5, 2012
Last Updated: April 2, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Salivary Gland Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases

ClinicalTrials.gov processed this record on July 24, 2014