Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	CASE-CWRU-1301 NCI-5389, CWRU-050212, NCT00049283, 5389, CASE-1301

Objectives

1. Determine the maximum tolerated dose of erlotinib when administered with docetaxel and radiotherapy in patients with locally advanced squamous cell cancer of the head and neck.
2. Determine the toxicity of this regimen in these patients.
3. Determine the pharmacokinetic profile of erlotinib alone and in combination with docetaxel in these patients.
4. Determine the overall and complete response rate in patients treated with this regimen.
5. Determine the overall, disease-free, and progression-free survival of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
  • Stage III or IV (locally advanced disease)
  • No distant metastatic disease



• Measurable disease



• No salivary gland or paranasal sinus squamous cell carcinoma



• No known brain metastases or direct cerebral invasion by tumor
  • Intracranial extension without cerebral involvement may be allowed

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent routine colony-stimulating factors

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified

Other

• No prior investigational antitumor drugs
• No other concurrent commercial or investigational anticancer agents or therapies

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy

• More than 12 weeks

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 10 g/dL

Hepatic

• Bilirubin normal
• AST/ALT no greater than 2 times upper limit of normal
• Prothrombin time normal

Renal

• Creatinine normal

  OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No clinically significant heart disease
• No New York Heart Association class III or IV heart disease
• No significant arrhythmias requiring medication
• No symptomatic coronary artery disease
• No myocardial infarction within the past 6 months
• No second- or third-degree heart block or bundle branch block
• No symptomatic congestive heart failure
• No unstable angina pectoris

Other

• No prior allergic reactions attributed to compounds of similar chemical or biological composition to erlotinib or docetaxel, including other drugs formulated with polysorbate 80
• No pre-existing peripheral neuropathy grade 2 or greater
• No other concurrent uncontrolled illness that would preclude study participation
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study participation
• No other malignancy within the past 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
• No patients who are considered poorly compliant
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

Approximately 30 patients will be accrued for this study.

Outcomes

Toxicity as measured by physical exams every 2 weeks during treatment, and blood tests weekly
Disease response measured 6-8 weeks after completion of study treatment
Maximum tolerated dose as measured by CTC v3.0 at end of phase I study

Outline

This is a dose-escalation study of erlotinib and docetaxel.

Patients receive oral erlotinib alone daily on weeks 1 and 2. Patients then receive oral erlotinib daily beginning on day 1 and docetaxel IV over 1 hour on day 3 of weeks 3-9. Patients also undergo radiotherapy once daily 5 days a week on weeks 3-9. Patients continue erlotinib for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients who had N2 or greater cervical lymph node involvement at baseline or have residual neck adenopathy after chemoradiotherapy undergo neck dissection 6-8 weeks after completion of chemoradiotherapy. Erlotinib is held for 1 week before planned surgery and until healing is complete.

Cohorts of 3-6 patients receive escalating doses of erlotinib and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 16 weeks for 1 year after completion of erlotinib, every 24 weeks for 2 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Case Comprehensive Cancer Center

Scot Remick, MD, Protocol co-chair		Ph: 216-844-5412
Panos Savvides, MD, Protocol chair		Ph: 216-844-5946

Registry Information
Official Title		A Phase I Study of the Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, OSI-774, in Combination with Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck
Trial Start Date		2002-09-20
Trial Completion Date		2003-03-19 (estimated)
Registered in ClinicalTrials.gov		NCT00049283
Date Submitted to PDQ		2002-09-11
Information Last Verified		2006-12-03
NCI Grant/Contract Number		CA62502, CA43703

Back to Top