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Phase I/II Dose Escalation Trial of Induction and Concomitant Erlotinib and Celecoxib With Radiation Therapy for Treatment of Poor Prognosis Head and Neck Cancer, Including Reirradiation

Phase 1/Phase 2
18 Years
Open (Enrolling)
Cancer of the Pharynx, Cancer of the Larynx, Cancer of the Neck, Paranasal Sinus Neoplasms, Cancer of the Head

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Trial Information

Phase I/II Dose Escalation Trial of Induction and Concomitant Erlotinib and Celecoxib With Radiation Therapy for Treatment of Poor Prognosis Head and Neck Cancer, Including Reirradiation

Despite advances in the treatment of head and neck cancer, locoregional recurrences are the
predominant site of treatment failure and are frequently the cause of death. Second primary
tumors in the head and neck occur in up to 30% of patients at 10 years of follow-up after
eradication of the original tumor due to field cancerization. The standard approach to
patients with recurrent but non-metastatic disease has been surgical salvage alone.
Unfortunately, this strategy is feasible in only a select group of patients and 5 year
survival rates have ranged from 15-40%.

Most patients with previously irradiated unresectable recurrent or metastatic head and neck
cancer are treated with chemotherapy alone. This approach has offered limited palliation
with response rates of 10-40%, median survival of 5 to 10 months. While this may be an
acceptable option for patients with clearly incurable widespread metastatic disease, it may
not be the best approach for those patients with potentially curable locoregional disease.

While geographic misses and second primary tumors occur, the majority of patients have
radioresistant tumors. Therefore, reirradiation alone is unlikely to be effective. High dose
reirradiation with concomitant chemotherapy represents a more aggressive approach resulted
in encouraging 3-year survival rates of 15 to 35%. This approach represents a potentially
curative option for patients with unresectable or partially resected disease arising in a
previously irradiated volume. However, the high rates of acute and late toxicity with this
approach have limited widespread application of this approach.

Extensive preclinical and clinical data suggest that both epidermal growth factor receptor
(EGFR) antagonists and cycloxygenase-2 (COX-2) inhibitors enhance the effectiveness of
ionizing radiation. In locally advanced head and neck cancer, a recent phase III trial
concurrent anti-EGFR monoclonal antibody and radiation demonstrated improved local control,
disease free survival and overall survival compared to radiation alone without the increased
mucosal toxicity associated with concurrent chemotherapy. COX-2 inhibition and anti-EGFR
therapy demonstrates activity against recurrent/metastatic head and neck cancer in a recent
phase I study. Head and neck cancer represents an ideal site to study biologic markers of
tumor response because of the accessibility of tumors for biopsy. Therefore, we propose the
combination of Erlotinib and Celecoxib with radiation in a cohort of previously irradiation
patients with head and neck cancer.

Inclusion Criteria:

- Age 18 years or older

- Histologically or cytologically confirmed diagnosis of squamous cell or poorly
differentiated carcinomas of the head and neck or lymphoepithelioma

- Prior radiation to the head and neck, surgery or chemotherapy is allowed

- Karnofsky performance status of >= 70%

- Intact organ and bone marrow function

- Obtained informed consent

Exclusion Criteria:

- Demonstration of metastatic disease (i.e. M1 disease).

- Incomplete healing from previous surgery

- Pregnancy or breast feeding (men and women of child-bearing potential are eligible
but must consent to using effective contraception during therapy and for at least 3
months after completing therapy)

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure (CHF), unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements

- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any
history of clinically significant CHF are excluded. The exclusion of patients with
active coronary artery disease will be at the discretion of the attending physician.

- Uncontrolled active infection unless curable with treatment of their cancer.

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:

Acute toxicity

Outcome Time Frame:


Safety Issue:


Principal Investigator

Johnny Kao, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine


United States: Institutional Review Board

Study ID:

GCO # 06-0509



Start Date:

February 2007

Completion Date:

November 2010

Related Keywords:

  • Cancer of the Pharynx
  • Cancer of the Larynx
  • Cancer of the Neck
  • Paranasal Sinus Neoplasms
  • Cancer of the Head
  • Neoplasms
  • Laryngeal Neoplasms
  • Head and Neck Neoplasms
  • Paranasal Sinus Neoplasms
  • Pharyngeal Neoplasms



Mount Sinai School of MedicineNew York, New York  10029