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

NCT00720304 | Completed Phase 2 Results DMC

• 1 other identifier: CASE5307
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

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; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage III verrucous carcinoma of the oral cavity; stage IV verrucous carcinoma of the oral cavity; metastatic squamous neck cancer with occult primary squamous cell carcinoma; stage III squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (2)

• Percent of Participants With Disease-Free Survival (DFS) at 3 Years

  Percent of participants with Disease-Free survival (DFS) at 3 years. Assessed from date of treatment to date of death or date of disease progression, and to date of last follow-up for those still alive and progression free. Disease-free Survival percentages were calculated using Kaplan-Meier estimates.

  3 yrs after treatment

• Time to Progression (TTP)

  Time from start of treatment to first documented occurrence of progressive disease (PD). PD defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  3 yrs after treatment

Secondary Outcomes (7)

• Response Rate (Complete Response, Partial Response, Stable Disease, and Disease Progression)

  3 yrs after treatment

• Overall Survival (OS)

  3 years

• Number of Participants With Acute Grade III/IV Treatment-related Toxicities

  evaluated every 2 weeks, up to 3 years

• Percent of Participants With Local Failure-free Survival

  At 3 years

• Percent of Participants With Regional Failure-free Survival

  At 3 years

Other Outcomes (1)

• Predictive Values of EGFR/TGF-α, VEGF

  collection at baseline and periodically during study.

Study Arms (1)

oral erlotinib hydrochloride

EXPERIMENTAL

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

Interventions

docetaxel DRUG

Beginning on week 3, patients receive docetaxel IV over 1 hour once a week

oral erlotinib hydrochloride

erlotinib hydrochloride DRUG

oral erlotinib hydrochloride once daily for up to 2 years in the absence of disease progression or unacceptable toxicity

oral erlotinib hydrochloride

fluorescence in situ hybridization GENETIC

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.

oral erlotinib hydrochloride

polymerase chain reaction GENETIC

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.

oral erlotinib hydrochloride

immunoenzyme technique OTHER

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.

oral erlotinib hydrochloride

immunohistochemistry staining method OTHER

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.

oral erlotinib hydrochloride

laboratory biomarker analysis OTHER

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.

oral erlotinib hydrochloride

pharmacological study OTHER

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.

oral erlotinib hydrochloride

therapeutic conventional surgery PROCEDURE

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.

oral erlotinib hydrochloride

intensity-modulated radiation therapy RADIATION

radiotherapy (may be intensity-modulated) once daily for 8 weeks in the absence of disease progression or unacceptable toxicity.

oral erlotinib hydrochloride

radiation therapy RADIATION

radiotherapy (may be intensity-modulated) once daily for 8 weeks in the absence of disease progression or unacceptable toxicity.

oral erlotinib hydrochloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Docetaxel; Erlotinib Hydrochloride; In Situ Hybridization, Fluorescence; Polymerase Chain Reaction; Immunoenzyme Techniques; Immunohistochemistry; Radiotherapy, Intensity-Modulated; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Nucleic Acid Amplification Techniques; Immunoassay; Immunologic Techniques; Molecular Probe Techniques; Histocytochemistry; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Therapeutics

Limitations and Caveats

Outcomes data from 6 participants who received the same treatment on CWRU1301 (NCT00049283) were including in the results for this record.

Results Point of Contact

• Title: Dr. Min Yao, MD
• Organization: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

CTUReferral@UHhospitals.org

1-800-641-2422

Study Officials

• Min Yao, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2008
• First Posted: July 22, 2008
• Study Start: November 19, 2007
• Primary Completion: November 13, 2015
• Study Completion: November 13, 2015
• Last Updated: August 22, 2024
• Results First Posted: August 22, 2024

Record last verified: 2024-08

Locations

US (1)