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

Inclusion Criteria

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)

- 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.

- 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.

- Patients must have adequate hepatic function as evidenced by bilirubin ≤ 1.5 times
the upper limit of normal (ULN) and alanine aminotransferase (ALT), and aspartate
aminotransferase (AST) ≤ 3 x ULN (in the case of liver metastases ALT and AST ≤ 5 x
ULN).

- Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or
below, except for alopecia.

- Patients must be willing and able to comply with the study protocol for the duration
of the study.

- Patients must give written informed consent prior to any study-specific screening
procedures with the understanding that the patient may withdraw consent at any time
without prejudice.

- No other active invasive malignancy unless disease free for at least 2 years.

Exclusion Criteria

- In the final expansion cohort, no prior treatment with 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 cetuximab.

- 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.

- Patients with brain or subdural metastases are not eligible, unless they have
completed local therapy and have discontinued the use of corticosteroids for this
indication for at least 4 weeks before starting treatment in this study. Any signs
(e.g., radiologic) and/or symptoms of brain metastases must be stable for at least 4
weeks.

- 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