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A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer

A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer With an Expansion Cohort For Head and Neck Cancer: A Brown University Oncology Research Group Study

NCT01744340•howard safran

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if the full dose of eribulin mesylate can be safely given with the full dose of cetuximab. The activity of the combination of eribulin mesylate and cetuximab on recurrent head and neck cancer and colon cancer will also be assessed.

Detailed Description

To determine if eribulin mesylate, up to a maximum dose of 1.4 mg/m2 day 1 and 8 of a 21 day cycle, can be safely combined with full dose cetuximab for patients with advanced head and neck cancer and colon cancer

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed advanced squamous cell cancer of the head and neck with progression after at least one prior therapy. (Chemoradiation is considered one line of therapy). Patients with unknown Head and Neck primaries are also eligible
•In the dose escalation cohorts, patients with advanced colon adenocarcinoma with wild-type kras who have previously received at least two lines of therapy for advanced disease are eligible- No longer applicable post February 2013 as all patients have been enrolled to the dose escalation phase
•In the expansion phase for patients with advanced colorectal cancer, only patients with mutated kras who have previously received at least two lines of therapy for metastatic disease will be eligible. Pathology report from diagnosis and report documenting KRAS status to be sent to BrUOG. No longer applicable as this phase of the study has been closed as of 5/6/2014 secondary to the lack of efficacy and activity of the single agent.
•Life expectancy of at least 3 months
•Patients must be aged 18 years or older
•Patients with measurable tumors according to RECIST .
•Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
•No severe concurrent illness that would interfere with protocol therapy.
•Patients must have adequate renal function as evidenced by ≤1.5 mg/dL or creatinine clearance \> 40 mL/minute (min).
•Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) \> 1.5 x 109/L and platelet count \> 100 x 109/L.
+5 more criteria

Exclusion Criteria

•For Head and Neck patients, no progression while receiving an EGFR inhibitor or within 6 months of stopping treatment with an EGFR inhibitor.
•Patients who received chemotherapy or investigational therapy within 3 weeks before treatment initiation. Radiation must be completed within 2 weeks before treatment initiation.
•Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.
•Patients who participated in a prior eribulin mesylate clinical trial, whether or not they received eribulin mesylate.
•Patients with other significant disease or disorders that, in the investigator's opinion, would exclude the patient from the study.
•Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Peri-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
•Grade 2 or worse neuropathy.
•Significant cardiovascular impairment (history of congestive heart failure \> NYHA G II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia.
•QTc \> 500 msec

Locations (4)

Montefiore

The Bronx, New York, United States

Memorial Hospital

Pawtucket, Rhode Island, United States

Rhode Island Hospital

Providence, Rhode Island, United States

The Miriam Hospital

Providence, Rhode Island, United States

Key Dates

Start Date

May 1, 2012

Primary Completion Date

March 1, 2015

Completion Date

July 1, 2015

Last Updated

February 17, 2020

Enrollment

ACTUAL participants

Conditions

Head and Neck CancerColon Cancer

Interventions

Head and neck

DRUG

Colon- Closed as of May 2014

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer

Inclusion Criteria

Exclusion Criteria

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