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

Alternate Title

Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	18 and over	NCI	OSU-02H0084 OSU-0213, NCI-5393, NCT00055770, 5393

Objectives

1. Determine the maximum tolerated dose and dose-limiting toxicity of erlotinib when administered in combination with docetaxel in patients with locally advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.
2. Determine the response rate, duration of response, time to progression, and survival of patients treated with this regimen.
3. Determine the pharmacokinetics of this regimen in these patients.
4. Correlate the presence of PTEN, RB, P-Akt, p15, p16, cyclin D1, p27, and p53 genes in tumor tissue with response in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck meeting 1 of the following staging criteria:
  • Recurrent
  • Metastatic
  • Locally advanced and determined to be incurable by surgery or radiotherapy



• Measurable disease



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• No prior immunotherapy for head and neck cancer

Chemotherapy

• No more than 1 prior chemotherapy regimen in the adjuvant or neoadjuvant setting
• No more than 1 prior chemotherapy regimen for metastatic disease
• No prior docetaxel (phase II only)
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

• No prior hormonal therapy for head and neck cancer

Radiotherapy

• Prior external beam radiotherapy allowed
• At least 4 weeks since prior radiotherapy and recovered

Surgery

• More than 21 days since prior major surgery
• No prior surgery affecting gastrointestinal absorption

Other

• No prior epidermal growth factor receptor-targeting therapy
• No other concurrent investigational agents
• No other concurrent anticancer therapies or agents
• No concurrent combination antiretroviral therapy for HIV-positive patients

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin normal
• AST and ALT no greater than 2.5 times upper limit of normal

Renal

• Creatinine normal

  OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Pulmonary

• No severe pulmonary insufficiency, including chronic obstructive pulmonary disease, requiring oxygen (O₂ saturation less than 90%) and/or increase in PaCO₂ blood gas level greater than 50 mm Hg

Ophthalmic

• No history of abnormality of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
• No congenital abnormality (e.g., Fuch's dystrophy)
• 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)

Gastrointestinal

• Able to take oral medication
• No requirement for IV alimentation
• No active peptic ulcer disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No significant traumatic injury within the past 21 days
• No prior allergic reactions to compounds of similar chemical or biological composition to study drugs
• No grade 2 or greater persistent peripheral neuropathy
• 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 compliance

Expected Enrollment

A total of 45 patients (15 patients for phase I and 36 patients [including 6 patients treated at the maximum tolerated dose in phase I] for phase II) will be accrued for this study within 15 months.

Outcomes

Maximum tolerated dose of erlotinib and docetaxel (Phase I)
Objective response (Phase II)

Response rate as measured by RECIST criteria (Phase II)
Time to tumor progression (Phase II)
Median survival (Phase II)

Outline

This is a phase I, dose-escalation study of erlotinib followed by a phase II study.

• Phase I: Patients receive oral erlotinib once daily on days 1-28 and docetaxel IV over 1 hour on days 8, 15, and 22. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

  Patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 6 patients receives erlotinib at the MTD.




• Phase II: Patients receive erlotinib at the MTD and docetaxel as in phase I.

Trial Contact Information

Trial Lead Organizations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Eric Kraut, MD, Protocol chair		Ph: 614-293-2887

Registry Information
Official Title		A Phase I and Phase II Study of OSI-774 in Combination with Docetaxel in Squamous Cell Carcinoma of the Head and Neck
Trial Start Date		2003-02-05
Trial Completion Date		2009-02-20
Registered in ClinicalTrials.gov		NCT00055770
Date Submitted to PDQ		2003-01-14
Information Last Verified		2006-12-11
NCI Grant/Contract Number		CA16058, CA76576

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