A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer
- Conditions
- Head and Neck CancerColon Cancer
- Interventions
- Drug: Head and neckDrug: Colon- Closed as of May 2014
- Registration Number
- NCT01744340
- Lead Sponsor
- howard safran
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description head and neck Head and neck Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2 Colon- closed as of May 2014 Colon- Closed as of May 2014 Eribulin Mesylate: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle
- Primary Outcome Measures
Name Time Method 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. From Day 1 of Drug through end of cycle 2 equals (approximately) 42 days 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
- Secondary Outcome Measures
Name Time Method 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 This shows patients able to achieve Stable disease or better as their best response during course of study participation. Response will be evaluated by Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline v1.1 RECIST Guideline version 1.1 Response Criteria Complete Response:Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease:At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Stable Disease:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Trial Locations
- Locations (4)
Montefiore
🇺🇸Bronx, New York, United States
Memorial Hospital
🇺🇸Pawtucket, Rhode Island, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States