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

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ClinicalTrials.gov Identifier: NCT01613768
Recruitment Status : Completed
First Posted : June 7, 2012
Results First Posted : August 10, 2018
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Renato Martins, University of Washington

Tracking Information
First Submitted Date  ICMJE June 5, 2012
First Posted Date  ICMJE June 7, 2012
Results First Submitted Date  ICMJE July 10, 2018
Results First Posted Date  ICMJE August 10, 2018
Last Update Posted Date September 28, 2018
Actual Study Start Date  ICMJE May 8, 2012
Actual Primary Completion Date August 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
Response Rate [ Time Frame: 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. ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, summarized using frequencies and percentages.
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2012)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
  • Duration of Tumor Response (Complete (CR) and Partial (PR) Response Only) [ Time Frame: 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. ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, reported as median values.
  • Time to Progression [ Time Frame: From date of first study therapy until date of first documented disease progression or date of death from any cause, whichever occurred first, assessed up to 36 days post last dose of study therapy. ]
    Either 1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Progressive Disease (PD), > 20% increase in the sum of the longest diameter (SLD) target lesions taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir; or 2. Radiographic progression per treating physician CT or MRI scan review.
  • Disease Control Rate (DCR) [ Time Frame: 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. ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage (compared to baseline) to qualify for partial or complete response (CR or PR) nor sufficient increase (taking as reference the smallest sum of diameters at baseline or while on study, whichever is smallest) to qualify for progressive disease (PD); Disease Control Rate (DCR) = CR + PR +SD.
  • Toxicity Rates [ Time Frame: Adverse events collected from the time patient received the first dose of study therapy through 36 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 36 days post therapy. ]
    Overall percentage of patients experiencing Grade 3 or higher toxicity, graded by National Cancer Institute (NCI) Common Toxicity Criteria Version 4.0
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2012)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer
Official Title  ICMJE 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 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent Salivary Gland Cancer
  • Stage IVA Salivary Gland Cancer
  • Stage IVB Salivary Gland Cancer
  • Stage IVC Salivary Gland Cancer
Intervention  ICMJE Drug: eribulin mesylate
Given IV
Other Names:
  • B1939
  • E7389
  • ER-086526
  • halichrondrin B analog
Study Arms  ICMJE 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.
Intervention: Drug: eribulin mesylate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2012)
29
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 23, 2017
Actual Primary Completion Date August 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01613768
Other Study ID Numbers  ICMJE 7674
NCI-2012-00892 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Renato Martins, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Renato Martins, MD, MPH Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
PRS Account University of Washington
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP