Sponsor study identifier
interventional
23
1 country
4
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
July 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 23, 2012
Actual (reported)May 2012
Date type not reportedThis date has not been verified as actual or estimated.
December 6, 2012
Actual (reported)March 2015
Actual (reported)July 2015
Actual (reported)February 10, 2016
Actual (reported)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.
A DLT was defined as: * Grade 4 neutropenia (ANC \< 500/mm3) for \> 7 days * ANC \<1000/mm3 with fever or infection * Platelets \<25,000/mm3 * Platelets \<50,000/mm3 requiring transfusion * Grade 3 or grade 4 treatment related non-hematologic toxicities excluding alopecia. Grade 3 nausea, vomiting or diarrhea will only be considered a dose limiting toxicity if it occurs despite maximal medical support. Grade 3 or grade 4 hypomagnesemia will not be considered a dose limiting toxicity since it is an expected side effect of cetuximab and can be corrected. Other grade 3 or grade 4 electrolyte abnormalities will not be considered dose limiting toxicities if the electrolyte disorder can be corrected to grade 2 or less within 72 hours. * EGFR dermatologic toxicity should be graded according to the toxicity scale for EGFR associated reactions. The first episode of grade 3 or grade 4 rash will not be considered a DLT. * If any patient receives \< 70% of the planned dose of eribulin mesylat
From Day 1 of Drug through end of cycle 2 equals (approximately) 42 days
Response Rate (Whether Patient's Disease is Progressing or Being Controlled) of Patients With Head and Neck Cancer Treated With Eribulin Mesylate and Cetuximab.
From beginning of treatment to progression of disease, for an expected average of 1 year
Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2
Eribulin Mesylate: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle
Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle
Eribulin Mesylate: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle
Montefiore
The Bronx, New York, 10467, United States
Memorial Hospital
Pawtucket, Rhode Island, 02860, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02904, United States
Howard Safran, MD
Brown University
23 participants (actual enrollment reported by the registry).
First Submitted
February 23, 2012
First Posted
December 6, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 2015
Actual (reported)Study Completion
July 2015
Actual (reported)Last Updated
February 17, 2020
Results First Posted
February 10, 2016
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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