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

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ClinicalTrials.gov Identifier: NCT01744340
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : February 10, 2016
Last Update Posted : April 23, 2019
Sponsor:
Collaborators:
Fatima Memorial Hospital
Montefiore Medical Center
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
howard safran, Brown University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Head and Neck Cancer
Colon Cancer
Interventions Drug: Head and neck
Drug: Colon- Closed as of May 2014
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Head and Neck Colon- Closed as of May 2014
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Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2

Head and neck: 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

Colon- Closed as of May 2014: Eribulin Mesylate:

1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Period Title: Overall Study
Started 8 15
Completed 8 15
Not Completed 0 0
Arm/Group Title Head and Neck Colon- Closed as of May 2014 Total
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Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2

Head and neck: 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

Colon- Closed as of May 2014: Eribulin Mesylate:

1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Total of all reporting groups
Overall Number of Baseline Participants 8 15 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 15 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  62.5%
9
  60.0%
14
  60.9%
>=65 years
3
  37.5%
6
  40.0%
9
  39.1%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants 15 participants 23 participants
58.5
(45 to 70)
71
(41 to 86)
60.6
(41 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 15 participants 23 participants
Female
0
   0.0%
8
  53.3%
8
  34.8%
Male
8
 100.0%
7
  46.7%
15
  65.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 15 participants 23 participants
8 15 23
1.Primary Outcome
Title 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.
Hide Description

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
Time Frame From Day 1 of Drug through end of cycle 2 equals (approximately) 42 days
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Hide Analysis Population Description
Outcome measure that address the dose of 1.4 mg/m2,6 patients were treated (1 head and neck 5 colon). 12 patients were enrolled in the course of the MTD dose finding,10 colon and 2 head and neck. All other results sections are inclusive of all patients(dose finding +expansion cohort).
Arm/Group Title Head and Neck Colon- Closed as of May 2014
Hide Arm/Group Description:

Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2

Head and neck: 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

Colon- Closed as of May 2014: Eribulin Mesylate:

1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Overall Number of Participants Analyzed 1 5
Measure Type: Number
Unit of Measure: participants
0 0
2.Secondary Outcome
Title Response Rate (Whether Patient's Disease is Progressing or Being Controlled) of Patients With Head and Neck Cancer Treated With Eribulin Mesylate and Cetuximab.
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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

Time Frame From beginning of treatment to progression of disease, for an expected average of 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Head and Neck Colon- Closed as of May 2014
Hide Arm/Group Description:

Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2

Head and neck: 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

Colon- Closed as of May 2014: Eribulin Mesylate:

1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Overall Number of Participants Analyzed 8 15
Measure Type: Number
Unit of Measure: participants
6 2
Time Frame Adverse events were collected pre-study, within 72 hours of day 1 if each cycle, at day 8 of each cycle, at end of treatment visit and 30 days post last dose of drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Head and Neck Colon- Closed as of May 2014
Hide Arm/Group Description

Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2

Head and neck: 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

Colon- Closed as of May 2014: Eribulin Mesylate:

1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

All-Cause Mortality
Head and Neck Colon- Closed as of May 2014
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Head and Neck Colon- Closed as of May 2014
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/8 (62.50%)      1/15 (6.67%)    
Investigations     
S b(4), pleural effusion(4), Dyspnea(4), asp(4), lung inf (4), resp acidosis(4)  [1]  1/8 (12.50%)  1 0/15 (0.00%)  0
Acute respiratory failure (5)   1/8 (12.50%)  1 0/15 (0.00%)  0
Dyspnea(2), K(3) , MG(2) , ANC(3), Nausea(2), Vomitting(2)   1/8 (12.50%)  1 0/15 (0.00%)  0
Edema(3), dysphyagia(3), hemolytic Anemia(3), PLT(4), calcium(1),WBC(1) , lymph(3)   1/8 (12.50%)  1 0/15 (0.00%)  0
Hemorragic shock(5), HGB/Anemia(3), Chloride(1) , CO2(1) , AST(2), ALT(2) , PT(1)   1/8 (12.50%)  1 0/15 (0.00%)  0
COPDdyspnea(2),neutr(3),sepsis(4),anemia(2),Leuk(3),Lymph (3), Hypergly(2),Hypoca(2), Hypokal(1)  [2]  1/8 (12.50%)  1 0/15 (0.00%)  0
Dyspnea(1), Sepsis(4), Anemia(2), Lymphocyte decrease (3), Hypocalcemia(2)   1/8 (12.50%)  1 0/15 (0.00%)  0
Feb neut(3), neut(4),anemia(3), leuk(3),hypona(3), lymph(3) , CR(1), Ca(2), K(1), Gluc(1), MG(2)  [3]  1/8 (12.50%)  1 0/15 (0.00%)  0
Feb Neut(res).Neut(0),An(1),Leuk(0),Hypona(1),Lymph(1),CR(0),Ca(1),K(0),Gluc(0),MG(1),URI(2)O Muc(3)  [4]  1/8 (12.50%)  1 0/15 (0.00%)  0
Respiratory Infection (5)   1/8 (12.50%)  1 0/15 (0.00%)  0
Dyspnea(2), Febrile Neutropenia(3)   1/8 (12.50%)  1 0/15 (0.00%)  0
Dyspnea(2), Productive cough(2), Wheezing(3)   1/8 (12.50%)  1 0/15 (0.00%)  0
Dys(1),PrCo(0),Whez(0),Resp(4),An(3),HGB(3),Leuk(1),Lymph(3),ALB(2),CA(2),K(3),MG(2),PHOS(4),GLU(2)  [5]  1/8 (12.50%)  1 0/15 (0.00%)  0
Na(3), confusion(1), Fatigue(3), constipation(2), anorexia(3)   0/8 (0.00%)  0 1/15 (6.67%)  1
Indicates events were collected by systematic assessment
[1]
Shortness of breath (4), left pleural effusion (4) , Dyspnea (4), aspiration (4), lung infection (4), resp acidosis(4)
[2]
COPD exasp dyspnea (2), neutropenia(3), sepsis(4), anemia (2), Leukopenia(3),Lymphocyte decrease(3), Hyperglycemia(2),Hypocalemia(2), Hypokalemia(1)
[3]
Febrile neutropenia(3), neutropenia (4),anemia(3), leukopenia(3),hyponatremia(3) , lymphocyte count(3) , CR(1), Calcium(2), K (1), Gluc(1), MG(2)
[4]
Febrile Neutropenia (resolved). Neutropenia(0), Anemia(1), Leukopenia(0), Hyponatremia(1), Lymphocyte count(1), CR(0), Calcium(1), K(0), Gluc(0), MG(1),URI(2) , Oral Mucositis(3)
[5]
Dyspnea (1), Productive Cough (0), Wheezing (0), Respiratory failure (4), Anorexia (3), HGB(3), Leukopenia(1), Lymph(3), HypoALB(2), CA(2), K(3), MG(2), PHOS(4), GLU(2)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Head and Neck Colon- Closed as of May 2014
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/8 (100.00%)      15/15 (100.00%)    
Investigations     
Albumin   7/8 (87.50%)  7 7/15 (46.67%)  7
Allergic Rhinitis   1/8 (12.50%)  1 0/15 (0.00%)  0
ALK   0/8 (0.00%)  0 2/15 (13.33%)  2
ALT   2/8 (25.00%)  2 5/15 (33.33%)  5
Alopecia   2/8 (25.00%)  2 2/15 (13.33%)  2
Absolute Neutrafil Count   1/8 (12.50%)  1 6/15 (40.00%)  6
anemia/HGB/Hemolytic anemia   5/8 (62.50%)  5 7/15 (46.67%)  7
Anorexia   3/8 (37.50%)  3 2/15 (13.33%)  2
Anxiety   0/8 (0.00%)  0 1/15 (6.67%)  1
AST   2/8 (25.00%)  2 4/15 (26.67%)  4
arterial blood gas   1/8 (12.50%)  1 0/15 (0.00%)  0
Bilirubin   0/8 (0.00%)  0 2/15 (13.33%)  2
blurry vision   0/8 (0.00%)  0 1/15 (6.67%)  1
bleed-urination   1/8 (12.50%)  1 0/15 (0.00%)  0
bloat/dyspepsia   0/8 (0.00%)  0 2/15 (13.33%)  2
Calcium   2/8 (25.00%)  2 1/15 (6.67%)  1
Chills   2/8 (25.00%)  2 1/15 (6.67%)  1
Constipation   0/8 (0.00%)  0 3/15 (20.00%)  3
Cough/Productive cough   2/8 (25.00%)  2 0/15 (0.00%)  0
Creatinine   1/8 (12.50%)  1 1/15 (6.67%)  1
CO2   1/8 (12.50%)  1 0/15 (0.00%)  0
Chloride   1/8 (12.50%)  1 0/15 (0.00%)  0
Dehydration   2/8 (25.00%)  2 1/15 (6.67%)  1
Depression   1/8 (12.50%)  1 1/15 (6.67%)  1
Dizziness   3/8 (37.50%)  3 1/15 (6.67%)  1
Diarrhea   2/8 (25.00%)  2 2/15 (13.33%)  2
dry skin/pruritis/itching   0/8 (0.00%)  0 3/15 (20.00%)  3
Dysgeusia   0/8 (0.00%)  0 1/15 (6.67%)  1
Dysphagia   1/8 (12.50%)  1 0/15 (0.00%)  0
dry mouth   2/8 (25.00%)  2 0/15 (0.00%)  0
EGFR   1/8 (12.50%)  1 0/15 (0.00%)  0
erythema (periorbital, ear,facial flushing)   1/8 (12.50%)  1 2/15 (13.33%)  2
Fatigue   7/8 (87.50%)  7 9/15 (60.00%)  9
Fever   1/8 (12.50%)  1 2/15 (13.33%)  2
Glucose   2/8 (25.00%)  2 0/15 (0.00%)  0
H/A   2/8 (25.00%)  2 4/15 (26.67%)  4
hemoptysis   1/8 (12.50%)  1 0/15 (0.00%)  0
hypersensitivity rxn   0/8 (0.00%)  0 2/15 (13.33%)  2
Hypotension   2/8 (25.00%)  2 1/15 (6.67%)  1
infection  [1]  1/8 (12.50%)  1 4/15 (26.67%)  4
Irritability   0/8 (0.00%)  0 1/15 (6.67%)  1
Insomnia   1/8 (12.50%)  1 1/15 (6.67%)  1
Potassium   5/8 (62.50%)  5 7/15 (46.67%)  7
Lymphopenia/Lymphocytes   3/8 (37.50%)  3 4/15 (26.67%)  4
m/a (myalgia), weakness   4/8 (50.00%)  4 0/15 (0.00%)  0
Magnesium   3/8 (37.50%)  3 1/15 (6.67%)  1
muscle cramps   1/8 (12.50%)  1 1/15 (6.67%)  1
Mucositis, tongue and general   4/8 (50.00%)  4 2/15 (13.33%)  2
Sodium   7/8 (87.50%)  7 3/15 (20.00%)  3
nausea   3/8 (37.50%)  3 4/15 (26.67%)  4
neuropathy   3/8 (37.50%)  3 3/15 (20.00%)  3
sores mouth/lips   0/8 (0.00%)  0 1/15 (6.67%)  1
pain (general, abd,back,rib, chest, jaw, mouth,throat, hand, neck, head)   5/8 (62.50%)  5 4/15 (26.67%)  4
pericardial effusion   1/8 (12.50%)  1 0/15 (0.00%)  0
PT lab   1/8 (12.50%)  1 0/15 (0.00%)  0
Rash, acneform, pistula   5/8 (62.50%)  5 7/15 (46.67%)  7
rectal bleed/GI hemorrhage   0/8 (0.00%)  0 2/15 (13.33%)  2
Shortness Of Breath/dyspnea   0/8 (0.00%)  0 1/15 (6.67%)  1
thrombocytopenia   0/8 (0.00%)  0 1/15 (6.67%)  1
trismus   1/8 (12.50%)  1 0/15 (0.00%)  0
troponin   1/8 (12.50%)  1 0/15 (0.00%)  0
vomitting   3/8 (37.50%)  3 2/15 (13.33%)  2
watery eyes   0/8 (0.00%)  0 1/15 (6.67%)  1
White Blood Cells/leukopenia   3/8 (37.50%)  3 9/15 (60.00%)  9
wt loss   5/8 (62.50%)  5 2/15 (13.33%)  2
Phosphorus   3/8 (37.50%)  3 0/15 (0.00%)  0
sleep disorder   1/8 (12.50%)  1 0/15 (0.00%)  0
chest tightness   1/8 (12.50%)  1 0/15 (0.00%)  0
Hypoxemia   1/8 (12.50%)  1 0/15 (0.00%)  0
Delirium   1/8 (12.50%)  1 0/15 (0.00%)  0
Vision loss   1/8 (12.50%)  1 0/15 (0.00%)  0
DVT   0/8 (0.00%)  0 1/15 (6.67%)  1
Indicates events were collected by systematic assessment
[1]
(eye, lung, mucosal, skin, parasitic, cellulitis g-tube, sepsis, Upper respiratory, thrush )
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Howard Safran, MD
Organization: BrUOG-Brown University Oncology Research Group
Phone: 4018633000
Responsible Party: howard safran, Brown University
ClinicalTrials.gov Identifier: NCT01744340     History of Changes
Other Study ID Numbers: BrUOG 254
First Submitted: February 23, 2012
First Posted: December 6, 2012
Results First Submitted: January 12, 2016
Results First Posted: February 10, 2016
Last Update Posted: April 23, 2019