- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00720304
Erlotinib, Docetaxel, and Radiation Therapy in Stage III or Stage IV Squamous Cell Carcinoma of the Head and Neck
A Phase II Study of the Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, Erlotinib, in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with docetaxel and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well erlotinib given together with docetaxel and radiation therapy works in treating patients with stage III or stage IV squamous cell carcinoma of the head and neck.
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: docetaxel
- Drug: erlotinib hydrochloride
- Genetic: fluorescence in situ hybridization
- Genetic: polymerase chain reaction
- Other: immunoenzyme technique
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Other: pharmacological study
- Procedure: therapeutic conventional surgery
- Radiation: intensity-modulated radiation therapy
- Radiation: radiation therapy
Detailed Description
OBJECTIVES:
Primary
- Determine the time to progression in patients with locally advanced squamous cell carcinoma of the head and neck treated with erlotinib hydrochloride in combination with docetaxel and radiotherapy.
Secondary
- Determine objective response rate, locoregional control rate, duration of response, patterns of failure, and overall survival in patients treated with this regimen.
- Determine the toxicities of this regimen in these patients.
- Determine the dose and effect of this treatment on biologic correlates in tumor tissue and/or surrounding mucosa.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Beginning on week 3, patients receive docetaxel IV over 1 hour once a week and radiotherapy (may be intensity-modulated) once daily for 8 weeks in the absence of disease progression or unacceptable toxicity.
At 6-8 weeks after completion of chemoradiotherapy, patients with N2 or greater cervical lymph node involvement at baseline or with residual disease may undergo surgery. Patients with persistent disease during study therapy undergo salvage surgery 6-12 weeks after completion of chemoradiotherapy.
Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study. Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA), immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.
After completion of study therapy, patients will be evaluated every 4-8 weeks for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then once a year thereafter.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ohio
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Cleveland, Ohio, United States, 44106-5065
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed locally advanced squamous cell carcinoma of the head and neck
Stage III or IV disease
- No distant metastatic disease
- Measurable disease (according to RECIST)
- No salivary gland and paranasal sinus squamous cell carcinoma
No known brain metastases or direct cerebral invasion by tumor
- Intracranial extension (without cerebral involvement) may be allowed
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy > 12 weeks
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥10 g/dL
- Total bilirubin normal
Alkaline phosphatase AND AST and ALT meeting the following criteria:
- Alkaline phosphatase normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN AND AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 5 times ULN AND AST and ALT normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
No clinically significant heart disease including any of the following:
- NYHA class III or IV heart disease
- Significant arrhythmias requiring medication
- Symptomatic coronary artery disease
- Myocardial infarction within the previous six months
- Second- or third-degree heart block or bundle-branch block
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after completion of study therapy
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib hydrochloride or docetaxel, including other drugs formulated with polysorbate 80
- No pre-existing peripheral neuropathy ≥ grade 2
No uncontrolled concurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would preclude compliance with study requirements
- No HIV positivity
No other prior malignancy except for any of the following:
- Squamous cell or basal cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Cancer that was treated more than 5 years ago and the patient has remained disease-free
- Not poorly compliant
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or investigational antitumor drug
- No other concurrent investigational agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: oral erlotinib hydrochloride
|
Beginning on week 3, patients receive docetaxel IV over 1 hour once a week
oral erlotinib hydrochloride once daily for up to 2 years in the absence of disease progression or unacceptable toxicity
Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study.
Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA), immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.
Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study.
Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA), immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.
Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study.
Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA), immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.
Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study.
Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA), immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.
Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study.
Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA), immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.
Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study.
Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA), immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.
At 6-8 weeks after completion of chemoradiotherapy, patients with N2 or greater cervical lymph node involvement at baseline or with residual disease may undergo surgery.Patients with persistent disease during study therapy undergo salvage surgery 6-12 weeks after completion of chemoradiotherapy.
radiotherapy (may be intensity-modulated) once daily for 8 weeks in the absence of disease progression or unacceptable toxicity.
radiotherapy (may be intensity-modulated) once daily for 8 weeks in the absence of disease progression or unacceptable toxicity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free-survival
Time Frame: 3 yrs after treatment
|
3 yrs after treatment
|
Time to progression
Time Frame: 3 yrs after treatment
|
3 yrs after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate (complete response, partial response, stable disease, and disease progression)
Time Frame: 3 yrs after treatment
|
3 yrs after treatment
|
Overall survival
Time Frame: evaluated every 4-8 weeks for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then once a year thereafter.
|
evaluated every 4-8 weeks for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then once a year thereafter.
|
Toxicities
Time Frame: evaluated every 2 weeks
|
evaluated every 2 weeks
|
Predictive values of EGFR/TGF-α, VEGF
Time Frame: collection at baseline and periodically during study.
|
collection at baseline and periodically during study.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Min Yao, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- stage III squamous cell carcinoma of the lip and oral cavity
- stage III verrucous carcinoma of the oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage IV verrucous carcinoma of the oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the nasopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage III verrucous carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- stage IV verrucous carcinoma of the larynx
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
- Carcinoma, Squamous Cell
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protein Kinase Inhibitors
- Docetaxel
- Erlotinib Hydrochloride
Other Study ID Numbers
- CASE5307 (Other Identifier: Case Comprehensive Cancer Center)
- P30CA043703 (U.S. NIH Grant/Contract)
- CASE-IRB-05-02-12 (Other Identifier: University Hospitals IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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