Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer

NCT00970502 | Completed Phase 1 Results DMC

• 1 other identifier: GCO 06-0509
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer of the Pharynx; Cancer of the Larynx; Cancer of the Neck; Paranasal Sinus Neoplasms; Cancer of the Head

Keywords

celecoxib; erlotinib; epidermal growth factor receptor; intensity-modulated radiotherapy; cyclooxygenase-2; reirradiation

Outcome Measures

Primary Outcomes (1)

• Toxicity

  Number of participants with acute and late toxicity

  30 DAYS

Secondary Outcomes (3)

• Clinical Response

  20 months

• Locoregional Progression

  20 months

• Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity

  1 year

Study Arms (1)

erlotinib + celecoxib

EXPERIMENTAL

Drug: erlotinib + celecoxib

Interventions

erlotinib + celecoxib DRUG

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

Also known as: Tarceva, Celebrex

erlotinib + celecoxib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johnny Kao: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (4)

• Salama JK, Vokes EE, Chmura SJ, Milano MT, Kao J, Stenson KM, Witt ME, Haraf DJ. Long-term outcome of concurrent chemotherapy and reirradiation for recurrent and second primary head-and-neck squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2006 Feb 1;64(2):382-91. doi: 10.1016/j.ijrobp.2005.07.005. Epub 2005 Oct 5.

  PMID: 16213104 BACKGROUND

• Kao J, Garofalo MC, Milano MT, Chmura SJ, Citron JR, Haraf DJ. Reirradiation of recurrent and second primary head and neck malignancies: a comprehensive review. Cancer Treat Rev. 2003 Feb;29(1):21-30. doi: 10.1016/s0305-7372(02)00096-8.

  PMID: 12633577 BACKGROUND

• J. Kao, S. H. Packer, M. Teng, V. Gupta, K. Misiukiewicz, E. M. Genden; Mount Sinai School of Medicine, New York, NY, J Clin Oncol 28:15s, 2010 (suppl; abstr 5561).

  BACKGROUND

• Kao J, Genden EM, Chen CT, Rivera M, Tong CC, Misiukiewicz K, Gupta V, Gurudutt V, Teng M, Packer SH. Phase 1 trial of concurrent erlotinib, celecoxib, and reirradiation for recurrent head and neck cancer. Cancer. 2011 Jul 15;117(14):3173-81. doi: 10.1002/cncr.25786. Epub 2011 Jan 18.

  PMID: 21246519 RESULT

MeSH Terms

Conditions

Pharyngeal Neoplasms; Laryngeal Neoplasms; Head and Neck Neoplasms; Paranasal Sinus Neoplasms

Interventions

Erlotinib Hydrochloride; Celecoxib

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Nose Neoplasms; Nose Diseases; Paranasal Sinus Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Johnny Kao
• Organization: Florida Radiation Oncology Group

johnnykaomd@gmail.com

813-661-6442

Study Officials

• Johnny Kao, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: February 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 10, 2017
• Results First Posted: April 10, 2017

Record last verified: 2017-02

Locations

US (1)