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Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Icahn School of Medicine at Mount Sinai.
Recruitment status was:  Recruiting
Information provided by:
Icahn School of Medicine at Mount Sinai Identifier:
First received: September 1, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
There is no optimal treatment for patients with recurrent head and neck cancer after previous radiation. Chemotherapy alone is not curative and patients survive an average of only 6 to 10 months. Surgery is not always possible and often cannot remove every cancerous cell. On the other hand, reirradiation with chemotherapy cures approximately 25 to 30% of patients but has significant toxicity with as many as 15 to 20% suffering from life-threatening or fatal complications. Therefore, less toxic and more effective reirradiation regimens are urgently needed. There are extensive data from animal studies and preliminary human studies showing that blocking epidermal growth factor receptor (EGFR) and COX-2 enhances radiation effect and is more effective than either treatment alone. Erlotinib is a FDA approved oral inhibitor of EGFR and celecoxib is a FDA approved COX-2 inhibitor. Both have been well studied in humans and appear to have less severe toxicity than conventional chemotherapeutic agents.

Condition Intervention Phase
Cancer of the Pharynx
Cancer of the Larynx
Cancer of the Neck
Paranasal Sinus Neoplasms
Cancer of the Head
Drug: erlotinib + celecoxib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Acute toxicity [ Time Frame: 30 DAYS ]

Secondary Outcome Measures:
  • locoregional control, progression-free survival, overall survival and late toxicity [ Time Frame: 2 YEARS ]

Estimated Enrollment: 30
Study Start Date: February 2007
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: erlotinib + celecoxib Drug: erlotinib + celecoxib
In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
Other Names:
  • Tarceva
  • Celebrex

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00970502

Contact: Johnny Kao, M.D. 212-241-7503
Contact: Stuart Packer, M.D. 212-241-8617

United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Johnny Kao, M.D    212-241-7503   
Contact: Stuart Packer, M.D    212-241-8617   
Principal Investigator: Johnny Kao, M.D.         
Sub-Investigator: Stuart Packer, M.D.         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Principal Investigator: Johnny Kao, M.D. Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Johnny Kao, M.D, Assistant Professor, Department of Radiation Oncology, Mount Sinai School of Medicine Identifier: NCT00970502     History of Changes
Other Study ID Numbers: GCO # 06-0509
Study First Received: September 1, 2009
Last Updated: September 1, 2009

Additional relevant MeSH terms:
Head and Neck Neoplasms
Pharyngeal Neoplasms
Paranasal Sinus Neoplasms
Laryngeal Neoplasms
Neoplasms by Site
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Nose Neoplasms
Nose Diseases
Respiratory Tract Diseases
Paranasal Sinus Diseases
Respiratory Tract Neoplasms
Laryngeal Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on March 22, 2017