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Phase II Trial of Induction Chemotherapy (ICT) Followed by Concurrent Chemoraditherapy (CR) With Monoclonal Antibody Cetuximab in Locally Advanced Head and Nec Squamous Cell Cancer

Phase 2
18 Years
Open (Enrolling)
Head and Neck Squamous Cell Cancer

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Trial Information

Phase II Trial of Induction Chemotherapy (ICT) Followed by Concurrent Chemoraditherapy (CR) With Monoclonal Antibody Cetuximab in Locally Advanced Head and Nec Squamous Cell Cancer


Chemotherapy would be used in two phases. In the initial phase all patients would be treated
with ICT involving 6 cycles of PCC. This involves Cetuximab 400mg/m2 Week 1 and then
250mg/m2 weekly, Paclitaxel 80mg/m2 weekly and carboplatin AUC 2 weekly for 6 weeks followed
by concurrent chemoradiotherapy with cetuximab. After ICT patients would be given weekly
Cisplatin at 30mg/m2 and cetuximab at 250mg/m2 concurrent with radiation therapy.

Radiation Therapy:

Typically for tumors treated by megavoltage (6MV) radiotherapy alone or with chemotherapy,
the primary tumor bed with an adequate margin and the draining lymphatics will be treated
with parallel opposed lateral treatment portals; the lower neck node bearing area will be
treated through an anterior port. The standard total dose for the targeted tumor bed and
electively treated lymphatics is 50 Gy/25 fractions, and then, an additional boost dose to
the neoplasm-bearing site(s) of 16 Gy to 20 Gy.

The total dose received by the spinal cord should not be allowed to exceed 46 Gy. For N1 to
N3 disease, they also shall need a total dose (boost included) of 66 Gy and perhaps up to 70
Gy if it can be safely given 6.4 Study Outline:

1. Patients who are deemed eligible and sign informed consent would be enrolled in the
clinical trial.

2. Prior to starting therapy staging PET/CT scan, medical history, physical exam,
hematologic and biochemical testing will be undertaken.

3. Since mucositis and oropharyngeal dysfunction is very likely with chemo-radiation PEG
tube placements will be considered prior to treatment, in order to allow adequate
nutrition in case of mucositis.

4. Prior to starting radiation patients would undergo dental evaluation which is a
standard practice.

5. Patients would then undergo 6 weeks of ICT using PCC. Based on toxicity dose would be
modified as described in section 8.

6. For PCC regimen, cetuxmiab would be given first followed by paclitaxel and then
carboplatin using standard pre-medication.

7. A CT scan (no PET scan) of the head and neck will be performed during the evaluation
Week 7 on any day of that week.

8. Following induction chemotherapy patients would be treated with radiation therapy of up
to 70 Gy concurrent with weekly Cisplatin at 30mg/m2 and cetuximab at 250mg/m2 for the
duration of radiation therapy. Again dose modifications would be performed based as
described in section 8.

9. Cetuximab would be administered first followed by cisplatin concurrent with radiation.

10. History and Physical examination would be performed at the end of treatment to document
response and assess toxicity

10. Patient with residual disease at the primary site or neck after completion of
chemoradiotherapy would be offered surgery.

11. Week 26 (3 months) after completion of radiation therapy a repeat PET scan will be
performed to assess response which is standard of care.

12. After completion of all treatment patients will be followed at every 3 months interval
to document relapse or manage toxicities from treatment.

Inclusion Criteria:

1. Adult patients 18 years and older with histologically proven locally advanced stage
III or IV unresectable Squamous cell head and neck cancer SCCHN (including cancers of
oral cavity, oropharynx, larynx and hypopharynx) with no evidence of distant

2. A careful evaluation for resection is required from the surgeon and criteria for
unresectability carefully defined for individual primary sites as follows:

- Hypopharynx: The tumor must extend across the midline of the posterior
pharyngeal wall or be fixed to the cervical spine

- Larynx: There must by either direct extension into surrounding muscle or skin or
greater than 3 cm of sub-glottic extension

- Oral cavity: The lesion must be so extensive that a functional reconstruction is
not possible.

- Base of Tongue: The tumor must extend into the roof of tongue, or the patient
must refuse a recommended total glossectomy

- Tonsil: The tumor must extend into the pterygoid region as manifested by
clinical trismus or demonstrated across the midline of the pharyngeal wall or
directly into soft tissue of the neck

- Patients with neck lymph node metastases fixed to the carotid artery, the
mastoid, the base of the skull, or the cervical spine are considered

- Medical unsuitability for resection is not sufficient for patient eligibility

- Patient's refusal for surgery except in case of total glossectomy is not
considered a reason for unresectibility

3. Patients must have received no prior treatment for head and neck cancer

4. ECOG Performance status 0-1

5. Adequate organ function (All labs should be obtained within 14 days prior to start of
study drug treatment)

- leukocytes > 3,000/mcL

- absolute neutrophil count > 1,500/mcL

- platelets > 100,000/mcL

- total Bilirubin within normal institutional limits

- AST (SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal

- creatinine within normal institutional limits or creatinine clearance > 60
mL/min/1.73 m2 for patients with creatinine levels above institutional normal

6. Ability to give informed consent and willingness to adhere to study protocol

7. Subjects of reproductive potential must agree to follow accepted birth control
methods during treatment and for 12 months after completion of treatment. Female
subject is either post-menopausal or surgically sterilized or willing to use an
acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with birth control (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study

Exclusion Criteria:

1. Patient who have had prior treatment for head and neck cancer

2. Prior history of radiation to head and neck area

3. Known malignancy other than the current cancer

4. Uncontrolled intercurrent illness including but not limited to ongoing active
infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable
angina, congestive heart failure, myocardial infarction within last six months or
ventricular arrhythmias requiring medication, psychiatric illness that would impair
patients ability to comply with study requirements

5. Pregnant or lactating women (any women becoming pregnant during the study will be
withdrawn from the study)

6. Patient with documented or symptoms of peripheral neuropathy

7. History of allergic reaction to compounds similar to the ones used in this study

8. Any condition that would hamper ability to give informed consent or ability to comply
with study protocol

9. HIV patients on anti-retroviral therapy are in-eligible to participate in this study
because of potential interaction with the study drugs and increase susceptibility for
infections during course of marrow suppressive chemotherapy and radiotherapy

Type of Study:


Study Design:

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

Outcome Measure:

Complete Response

Outcome Description:

Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

Outcome Time Frame:

Analysis at Week 26

Safety Issue:


Principal Investigator

Syed H Jafri, MB,B,S

Investigator Role:

Principal Investigator

Investigator Affiliation:

LSU shreveport


United States: Institutional Review Board

Study ID:




Start Date:

June 2010

Completion Date:

June 2014

Related Keywords:

  • Head and Neck Squamous Cell Cancer
  • Head
  • Neck
  • Locally advanced
  • Squamous Cell
  • Hypopharynx
  • Larynx
  • Oral Cavity
  • Base of Tongue
  • Tonsil
  • Neck lymph node
  • Resection
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell



LSU Health Sciences Center Shreveport, Louisiana  71130-3932