NCT01613768 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2018-09-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Response Rate

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outcome · POSTED

Duration of Tumor Response (Complete (CR) and Partial (PR) Response Only)

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outcome · POSTED

Time to Progression

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outcome · POSTED

Disease Control Rate (DCR)

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outcome · POSTED

Toxicity Rates

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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 Names
Drug: eribulin mesylate
label
Treatment (eribulin mesylate)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (eribulin mesylate)
description
Given IV
name
eribulin mesylate
other Names
B1939
E7389
ER-086526
halichrondrin B analog
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 29
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
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.

secondary Outcomes

description
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.
measure
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.
description
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.
measure
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.
description
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.
measure
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.
description
Overall percentage of patients experiencing Grade 3 or higher toxicity, graded by National Cancer Institute (NCI) Common Toxicity Criteria Version 4.0
measure
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.

Full study description

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.

Source references

Source notices and limitations

Discovery and provenance

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source kind
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end
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exact text
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start
0
offset unit
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query cond
Salivary Gland Cancer
query disease state id
ds-salivary-gland-cancer
source file
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source file sha256
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source json pointer
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source kind
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source record id
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Salivary+Gland+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice