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Concurrent Angiogenic and EGFR Blockade in Conjunction With Curative Intent Chemoradiation for Locally Advanced Head and Neck Cancer


Phase 0
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Pharynx Cancer

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Trial Information

Concurrent Angiogenic and EGFR Blockade in Conjunction With Curative Intent Chemoradiation for Locally Advanced Head and Neck Cancer


Pre Radiation Period:

- Bevacizumab (10 mg/kg) on days -14 and 0, or

- Tarceva (100 mg) daily from -14-0, or

- Bevacizumab (10 mg/kg) on days -14 and 0; Tarceva (100 mg) daily from -14-0

Chemoradiation Period:

- Radiotherapy may be delivered via conventional 2-D, conformal 3-D, or intensity
modulated (IMRT) technique as is clinically indicated. Radiotherapy and CDDP doses will
be delivered uniformly to all treatment cohorts:

- RT: 1.25 Gy BID M-F with a 6 hour interfraction interval

- Treatment break during week 4. Total dose 70 Gy/7 weeks

- CDDP: 33 mg/m2 M-W on weeks 1 and 5 of RT with standard DUMC hydration and
anti-emetic regimens

- Bevacizumab (10mg/kg): Monday of weeks 1, 3, 5, 7 of RT

- Tarceva (100 mg): Daily for weeks 1-7 of treatment, except for days receiving CDDP

Safety Assessments:

- Baseline and then weekly assessments of blood pressure and urine protein : creatinine
ratios during lead in and chemoRT phases of treatment

- Baseline carotid Doppler ultrasound evaluation

- Carotid Doppler ultrasound evaluation 1 month post-chemoRT

Efficacy Assessments:

- MR Imaging/Spectroscopy to be done at baseline, end of lead-in phase, end of week 1 of
chemoRT, and end of chemoRT

- Angiogenic and EGFR related cytokines. Specifically, blood samples will be obtained to
assay levels of VEGF, b-FGF, IL-8, D-dimer, EGF, TGF. These samples will be obtained
on the same dates as the MR studies with an additional set of samples obtained at the
midpoint of the lead in phase of treatment (day -7).

Clinical Assessments:

- All patients will undergo a minimum of once weekly interval history and physical
examination including fiberoptic pharyngoscopy/laryngoscopy when indicated in the
Department of Radiation Oncology to monitor for side effects and response to treatment
as per standard routine for the care of patients with head and neck cancer.

- Patient compliance with Tarceva administration monitored via diary MRI/MRS (Magnetic
Resonance Spectroscopy) DE-MRI


Inclusion Criteria:



- Locally advanced squamous carcinoma of the head and neck (AJCC stages II/IV, M0, and
excluding T1N1 and T1N2) undergoing curative intent concurrent chemoradiation.

- Previous treatment of any sort other than a biopsy is not allowed.

- Eligible anatomic sites:

- oral cavity

- oropharynx

- hypopharynx

- supraglottic

- glottic larynx

- KPS > 60

Exclusion Criteria:

- Nasopharynx primary

- History of malignancy other than basal cell skin cancer.

- History of claudication, bleeding, or thromboembolic disorders. Patients receiving
heparin or Coumadin therapy are ineligible.

- Primary tumor or lymph node encasement of the carotid artery

- Blood pressure of >150/100 mmHg

- Unstable angina

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- History of myocardial infarction within 6 months

- History of stroke within 6 months

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0; anticipation of need for major surgical procedure during the course
of the study.

- Minor surgical procedures, fine needle aspirations, or core biopsies within 7 days
prior to Day 0

- Pregnant (positive pregnancy test) or lactating

- Urine protein : creatinine ratio ≥ 1.0 at screening

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 0

- Serious, non-healing wound, ulcer, or bone fracture

- AST, ALT, or bilirubin > 1.5 x normal

- PT or PTT > 1.5 x normal

- Platelets < 100,000

- WBC < 2000

- Hgb < 10

- Creatinine clearance < 60 mL/hr

- Refusal to provide written informed consent

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tumor Resolution

Outcome Description:

Complete response (resolution) of tumor on clinical exam.

Outcome Time Frame:

Within 30 days of completing RT

Safety Issue:

No

Principal Investigator

David M Brizel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiation Oncology; Duke University Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

Pro00008840

NCT ID:

NCT00140556

Start Date:

August 2005

Completion Date:

April 2010

Related Keywords:

  • Head and Neck Cancer
  • Pharynx Cancer
  • head and neck cancer
  • targeted therapy
  • bevacizumab
  • erlotinib
  • Tarceva
  • radiotherapy
  • concurrent chemotherapy
  • pharynx cancer
  • tonsil cancer
  • hyperfractionation
  • angiogenesis
  • epidermal growth factor
  • vascular endothelial growth factor
  • magnetic resonance spectroscopy
  • cancer of the head and neck
  • upper aerodigestive tract neoplasms
  • pharynx neoplasms
  • Head and Neck Neoplasms
  • Pharyngeal Neoplasms

Name

Location
Department of Radiation Oncology; Duke University Medical Center Durham, North Carolina  27710