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Erlotinib, Docetaxel, and Radiation Therapy in Stage III or Stage IV Squamous Cell Carcinoma of the Head and Neck

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00720304
First received: July 19, 2008
Last updated: April 10, 2014
Last verified: March 2014

July 19, 2008
April 10, 2014
November 2007
February 2016   (final data collection date for primary outcome measure)
  • Progression-free-survival [ Time Frame: 3 yrs after treatment ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 3 yrs after treatment ] [ Designated as safety issue: No ]
  • Progression-free-survival [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00720304 on ClinicalTrials.gov Archive Site
  • Response rate (complete response, partial response, stable disease, and disease progression) [ Time Frame: 3 yrs after treatment ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Toxicities [ Time Frame: evaluated every 2 weeks ] [ Designated as safety issue: Yes ]
  • Predictive values of EGFR/TGF-α, VEGF [ Time Frame: collection at baseline and periodically during study. ] [ Designated as safety issue: No ]
  • Response rate (complete response, partial response, stable disease, and disease progression) [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicities [ Designated as safety issue: Yes ]
  • Predictive values of EGFR/TGF-α, VEGF [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: docetaxel
    Beginning on week 3, patients receive docetaxel IV over 1 hour once a week
  • Drug: erlotinib hydrochloride
    oral erlotinib hydrochloride once daily for up to 2 years in the absence of disease progression or unacceptable toxicity
  • Genetic: fluorescence in situ hybridization
    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.
  • Genetic: polymerase chain reaction
    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.
  • Other: immunoenzyme technique
    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.
  • Other: immunohistochemistry staining method
    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.
  • Other: laboratory biomarker analysis
    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.
  • Other: pharmacological study
    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.
  • Procedure: therapeutic conventional surgery
    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.
  • Radiation: intensity-modulated radiation therapy
    radiotherapy (may be intensity-modulated) once daily for 8 weeks in the absence of disease progression or unacceptable toxicity.
  • Radiation: radiation therapy
    radiotherapy (may be intensity-modulated) once daily for 8 weeks in the absence of disease progression or unacceptable toxicity.
Experimental: oral erlotinib hydrochloride
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
37
Not Provided
February 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00720304
CASE5307, P30CA043703, CASE5307, CASE-IRB-05-02-12
Yes
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Min Yao, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP