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An Exploratory Study to Assess the Modulation of Biomarkers in Patients With Squamous Cell Carcinomas of the Head and Neck Randomized to Receive Preoperative Treatment With Cetuximab and/or IMC-A12, an Anti-insulin-like Growth Factor-1 Receptor Monoclonal Antibody


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Squamous Cell Carcinoma

Thank you

Trial Information

An Exploratory Study to Assess the Modulation of Biomarkers in Patients With Squamous Cell Carcinomas of the Head and Neck Randomized to Receive Preoperative Treatment With Cetuximab and/or IMC-A12, an Anti-insulin-like Growth Factor-1 Receptor Monoclonal Antibody


The Study Drugs:

Cetuximab and IMC-A12 are both designed to block proteins that are thought to cause cancer
cells to grow. This may help to slow the growth of tumors.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the roll of dice) to 1 of 3 groups. There is an equal chance of being assigned to
any group.

- Group 1 will receive cetuximab alone.

- Group 2 will receive IMC-A12 alone.

- Group 3 will receive cetuximab and IMC-A12 in combination.

If you are assigned to group 2 or 3 you will have a hearing test within 90 days before
starting treatment with the study drug.

Study Treatment:

Groups 1 and 3:

Cetuximab will be given by vein on Days 1 and 8. The first dose will be given over 2 hours.
The second dose will be given over 1 hour.

To lower the risk of allergic reaction, Groups 1 and 3 will also receive diphenhydramine by
mouth or by vein before the first dose of cetuximab. If the study doctor decides it is
needed, diphenhydramine may also be given before the second dose of cetuximab (and the
third, if applicable).

Groups 2 and 3:

IMC-A12 will be given by vein over 1 hour on Days 1 and 8.

All Groups:

You will have surgery on Day 10. If for some reason the surgery is delayed, the study
doctor may decide that you will receive a third dose of your assigned study drug(s) on Day
15. In that case, cetuximab will be given over 1 hour and/or IMC-A12 will be given over 1
hour, depending on which group you are in.

You will sign a separate consent form that describes the surgery and its risks in more
detail.

Study Tests:

Within 5 days before your second dose of study drug(s), and again within 5 days before your
third dose (if applicable), the following tests and procedures will be performed:

- Your medical history will be recorded.

- You will be asked about any side effects you may be experiencing.

- You will have a physical exam, including measurement of vital signs.

- Blood (about 3 teaspoons) will be drawn for routine tests.

On the day before surgery, you will have a CT scan or MRI of the head and neck. If needed,
these tests can instead be done before surgery but sometime after the last dose of the study
drug(s).

On the day of surgery, blood (about 3 teaspoons) will be drawn for routine tests and your
vital signs will be measured. If needed, these tests can instead be done up to 2 days
before surgery.

Length of Study Drug Dosing:

After your last dose of the study drug(s), on Day 8 or Day 15, your participation in the
study treatment period will be over. You will be taken off the study drug(s) early if the
disease gets worse or intolerable side effects occur.

Follow-Up:

If you return to the clinic within 30 days after surgery, the following tests and procedures
will be performed:

- Your medical history will be recorded.

- You will have a physical exam, including measurement of your vital signs.

- You will be asked about any side effects that may have occurred.

Otherwise if you do not have a visit scheduled during that time, the study staff will call
you by phone instead. You will be asked how you are doing.

If you are experiencing side effects from the study drug(s) at the time of the follow-up
visit or call, you may have additional follow-up if the doctor decides it is needed. The
follow-up tests, procedures, and schedule will be the doctor's decision depending on the
side effects.

You will have a repeat hearing test within 90 days after surgery if you received at least 1
dose of IMC-A12.

Long-Term Follow-Up:

On a long-time basis after surgery, the study staff may review your medical record to
collect information about your health. During this time, you or your family members may be
contacted and asked to confirm or provide information about your health. The contact may
occur during clinic visits or by phone, mail, or e-mail.

This is an investigational study. Cetuximab is commercially available and FDA approved to
treat squamous cell carcinoma that has spread or come back, in patients who did not respond
to platinum-based therapy.

Using cetuximab in combination with surgery is investigational.

IMC-A12 is not FDA approved or commercially available. At this time, IMC-A12 is only being
used in research.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Histologically or cytologically-confirmed diagnosis of squamous cell carcinoma of the
head and neck (excluding carcinomas of the nasopharynx types II and III according to
the World Health Organization criteria), for whom surgical resection of the tumor is
planned as part of the treatment. Patients with skin squamous cell carcinomas of the
head and neck region will also be included in this study.

2. There is availability of a baseline, paraffin-embedded, tumor specimen for biomarker
evaluation. No anti-neoplastic treatment is allowed between the time from obtaining
the baseline tumor specimen and randomization. If a baseline tumor specimen is not
available, a biopsy of the tumor will be performed prior to randomization.

3. Prior treatment with biological agents targeted to the epidermal growth factor
receptor is allowed, provided the time from last exposure to this treatment was >/= 6
months.

4. The patient has a fasting serum glucose < 130 mg/dL and HbA1C < 7.0%. Patients with a
history of diabetes mellitus are allowed to participate, provided that they are on a
stable dietary or therapeutic regimen for this condition.

5. The patient has adequate renal function, defined by serum creatinine institutional upper limit of normal (ULN), or creatinine clearance >/=60 mL/min for
patients with creatinine levels above the ULN.

6. Because the teratogenicity of cetuximab and IMC-A12 is not known, women of
childbearing potential and men must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation.

7. The patient is age >/= 18 years.

8. The patient or the patient's legally authorized representative has the ability to
understand and the willingness to sign a written informed consent document.

9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion Criteria:

1. Patients receiving any other agent (investigational or not) with potential
anti-neoplastic activity within 3 weeks prior to obtaining the baseline tumor
specimen for biomarker evaluation.

2. Patients receiving concomitant radiation.

3. Prior treatment with an agent targeted at the insulin-like growth factor-1 receptor.

4. History of allergic reactions attributed to compounds of chemical and biological
composition similar to those of cetuximab or IMC-A12.

5. Pregnant patients, or patients who are breast feeding (patients who have a positive
pregnancy test within the first 30 days before the first dose of treatment are
excluded).

6. Patients with uncontrolled illnesses which, in the opinion of the investigator, could
be aggravated by the administration of the study drug(s).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Modulation of phospho-Akt (difference in IHC score between the surgical specimen and the baseline biopsy)

Outcome Time Frame:

Biopsy at baseline and surgery (surgery should be within 10 days of last treatment).

Safety Issue:

No

Principal Investigator

William N. William Jr., MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2008-0342

NCT ID:

NCT00957853

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Head and Neck Squamous Cell Carcinoma
  • Head and Neck Cancer
  • Squamous cell carcinoma of the head and neck
  • HNSCC
  • Cetuximab
  • IMC-A12
  • Tumor
  • Biomarkers
  • Phospho-AKT
  • Surgical resection
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030