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Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

This study has been completed.
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group ) Identifier:
First received: March 8, 2004
Last updated: November 25, 2016
Last verified: January 2011

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving erlotinib after chemoradiotherapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of adjuvant erlotinib when given after completing chemoradiotherapy in treating patients with locally advanced squamous cell carcinoma (cancer) of the head and neck.

Condition Intervention Phase
Head and Neck Cancer
Drug: erlotinib hydrochloride
Procedure: adjuvant therapy
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Adjuvant OSI-774 (Tarceva®) in Patients Following Combined Chemo-Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:

Further study details as provided by Canadian Cancer Trials Group:

Primary Outcome Measures:
  • Toxicity/feasibility assessed by NCI CTC v2.0 at the end of course 1
  • Recommended phase II dose at the end of course 1

Secondary Outcome Measures:
  • Correlative studies (archival and prospective) at accrual completion
  • Disease-free survival

Estimated Enrollment: 20
Study Start Date: November 2003
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:



  • Determine the recommended dose of adjuvant erlotinib after the completion of chemoradiotherapy in patients with stage III, IVA, or IVB squamous cell carcinoma of the head and neck.
  • Determine the toxicity of this drug in these patients.
  • Determine the effects of this drug on plasma and urinary angiogenic factors (specifically vascular endothelial growth factor receptor [VEGFR], VEGFR1, VEGFR2, and basic fibroblast growth factor levels) in these patients.
  • Compare the disease-free survival of patients treated with this drug after chemoradiotherapy vs historical control patients treated with chemoradiotherapy alone.
  • Correlate levels of angiogenic factors with initial blood vessel concentration in the tumor and the presence or absence of EGFRvIII mutation in patients treated with this drug.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive oral erlotinib once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 8 patients are treated at that dose level.

Patients are followed at 4 weeks, every 12 weeks for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed squamous cell carcinoma of the head and neck

    • Stage III, IVA, or IVB
  • Must have completed cisplatin- or carboplatin-based chemoradiotherapy within the past 4-12 weeks

    • Prior radiotherapy must have been given with a radical intent with receipt of at least 90% of planned dose
  • No evidence of disease or presence of inoperable minimal residual disease, defined by 1 of the following:

    • Complete response at primary tumor site and nodes (with or without nodal surgery after chemoradiotherapy)
    • Negative lymph node status (by physical or radiological exam) AND persistent tumefaction less than 25% of original tumor size or residual mass due to scarring
  • Tumor tissue samples available for EGFRvIII mutation analysis
  • No known brain metastasis



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • ALT/AST < 2 times upper limit of normal (ULN)
  • Bilirubin < ULN (unless due to Gilbert's syndrome)


  • Creatinine < 1.5 times ULN


  • No myocardial infarction within the past year
  • No cardiac ventricular arrhythmias requiring medication
  • No history of cardiac disease
  • No uncontrolled high blood pressure
  • No unstable angina
  • No congestive heart failure


  • No history of severe dry eye syndrome, Sjögren's syndrome, or keratoconjunctivitis sicca
  • No severe exposure keratopathy
  • No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
  • No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
  • No disorder that might increase the risk for epithelium-related complication (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
  • No congenital abnormality (e.g., Fuch's dystrophy)
  • No ocular inflammation or infection


  • Able to take oral medication
  • No gastrointestinal (GI) tract disease requiring IV alimentation
  • No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
  • No active peptic ulcer disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No serious active infection
  • No other serious underlying medical condition that would preclude study participation
  • No prior allergic reaction to compounds of similar chemical or biological composition to erlotinib
  • No other malignancy with the past 5 years except adequately treated non-melanoma skin cancer (unless in the same area treated with radical radiotherapy) or carcinoma in situ of the cervix


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • Recovered from prior chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • Recovered from prior radiotherapy


  • See Disease Characteristics
  • No prior surgical procedure affecting absorption
  • No concurrent ophthalmic surgery


  • More than 4 weeks since other prior investigational drugs
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased vigilance with respect to INR
  • Concurrent nasogastric or gastrostomy tube feeding for dysphagia allowed provided there is no evidence of significant residual mucositis (i.e., > grade 1)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00079053

London Regional Cancer Program
London, Canada, N6A 4L6
CHUM - Hopital Notre-Dame
Montreal, Canada, H2L 4M1
Sponsors and Collaborators
NCIC Clinical Trials Group
Study Chair: Denis Soulieres, MD, MSC CHUM - Hotel Dieu Hospital
  More Information

Responsible Party: NCIC Clinical Trials Group Identifier: NCT00079053     History of Changes
Other Study ID Numbers: HN5
CDR0000353485 ( Other Identifier: PDQ )
Study First Received: March 8, 2004
Last Updated: November 25, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Canadian Cancer Trials Group:
stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
salivary gland squamous cell carcinoma
stage III salivary gland cancer
stage IV salivary gland cancer

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017