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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Colon Cancer

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Trial Information

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


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

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity of eribulin mesylate combined with full dose cetuximab for patients with advanced head and neck cancer and colon cancer.

Outcome Time Frame:

From beginning of treatment to 30 days post being off drug, an expected average of 6 months

Safety Issue:

Yes

Principal Investigator

Howard Safran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brown University Oncology Research Group

Authority:

United States: Food and Drug Administration

Study ID:

BrUOG 254

NCT ID:

NCT01744340

Start Date:

May 2012

Completion Date:

January 2014

Related Keywords:

  • Head and Neck Cancer
  • Colon Cancer
  • Head and Neck
  • Colon
  • Colonic Neoplasms
  • Head and Neck Neoplasms

Name

Location

Rhode Island HospitalProvidence, Rhode Island  02903
The Miriam HospitalProvidence, Rhode Island  02903
Memorial HospitalPawtucket, Rhode Island  02860