Overview

This trial is active, not recruiting.

Conditions recurrent salivary gland cancer, stage iva salivary gland cancer, stage ivb salivary gland cancer, stage ivc salivary gland cancer
Treatment eribulin mesylate
Phase phase 2
Sponsor University of Washington
Collaborator National Cancer Institute (NCI)
Start date May 2012
End date December 2016
Trial size 29 participants
Trial identifier NCT01613768, 7674, NCI-2012-00892

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
eribulin mesylate B1939
Given IV

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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
Disease control rate (DCR), defined as stable disease + partial response rate
time frame: Up to 30 days after completion of study treatment
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Trial of Eribulin for Locally Advanced Refractory or Metastatic Salivary Gland Cancers
Principal investigator Renato Martins
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Washington.