NCT00720304 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2024-08-22

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Time to Progression (TTP)

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outcome · POSTED

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

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

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

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outcome · POSTED

Percent of Participants With Local Failure-free Survival

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outcome · NOT POSTED

Predictive Values of EGFR/TGF-α, VEGF

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outcome · POSTED

Percent of Participants With Regional Failure-free Survival

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outcome · POSTED

Percent of Participants With Locoregional Failure-free Survival

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outcome · POSTED

Percent of Participants With Distant Metastasis-free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
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
label
oral erlotinib hydrochloride
type
EXPERIMENTAL

interventions

arm Group Labels
oral erlotinib hydrochloride
description
Beginning on week 3, patients receive docetaxel IV over 1 hour once a week
name
docetaxel
type
DRUG
arm Group Labels
oral erlotinib hydrochloride
description
oral erlotinib hydrochloride once daily for up to 2 years in the absence of disease progression or unacceptable toxicity
name
erlotinib hydrochloride
type
DRUG
arm Group Labels
oral erlotinib hydrochloride
description
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.
name
fluorescence in situ hybridization
type
GENETIC
arm Group Labels
oral erlotinib hydrochloride
description
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.
name
polymerase chain reaction
type
GENETIC
arm Group Labels
oral erlotinib hydrochloride
description
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.
name
immunoenzyme technique
type
OTHER
arm Group Labels
oral erlotinib hydrochloride
description
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.
name
immunohistochemistry staining method
type
OTHER
arm Group Labels
oral erlotinib hydrochloride
description
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.
name
laboratory biomarker analysis
type
OTHER
arm Group Labels
oral erlotinib hydrochloride
description
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.
name
pharmacological study
type
OTHER
arm Group Labels
oral erlotinib hydrochloride
description
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.
name
therapeutic conventional surgery
type
PROCEDURE
arm Group Labels
oral erlotinib hydrochloride
description
radiotherapy (may be intensity-modulated) once daily for 8 weeks in the absence of disease progression or unacceptable toxicity.
name
intensity-modulated radiation therapy
type
RADIATION
arm Group Labels
oral erlotinib hydrochloride
description
radiotherapy (may be intensity-modulated) once daily for 8 weeks in the absence of disease progression or unacceptable toxicity.
name
radiation therapy
type
RADIATION

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 43
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

measure
Predictive Values of EGFR/TGF-α, VEGF
time Frame
collection at baseline and periodically during study.

primary Outcomes

description
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.
measure
Percent of Participants With Disease-Free Survival (DFS) at 3 Years
time Frame
3 yrs after treatment
description
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.
measure
Time to Progression (TTP)
time Frame
3 yrs after treatment

secondary Outcomes

description
Response rate according to response criteria, which defines the following: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): 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
measure
Response Rate (Complete Response, Partial Response, Stable Disease, and Disease Progression)
time Frame
3 yrs after treatment
description
Percent of participants alive at follow-up time. Overall survival time is evaluated from the date of treatment to date of death, and to date of last follow-up for those still alive.
measure
Overall Survival (OS)
time Frame
3 years
description
Number of participants with acute grade III/IV treatment-related toxicities
measure
Number of Participants With Acute Grade III/IV Treatment-related Toxicities
time Frame
evaluated every 2 weeks, up to 3 years
description
Participants with Local absence of relapse or recurrence or progression within the prescribed radiation field.
measure
Percent of Participants With Local Failure-free Survival
time Frame
At 3 years
description
Participants with the regional absence of relapse or recurrence or progression within the prescribed radiation field. Failure-free Survival percentages were calculated using Kaplan-Meier estimates.
measure
Percent of Participants With Regional Failure-free Survival
time Frame
At 3 years
description
Participants with the locoregional absence of relapse or recurrence or progression within the prescribed radiation field. Locoregional failure-free survival percentages were calculated using Kaplan-Meier estimates.
measure
Percent of Participants With Locoregional Failure-free Survival
time Frame
At 3 years
description
Percent of participants with distant metastasis-free survival
measure
Percent of Participants With Distant Metastasis-free Survival
time Frame
At 3 years

Full study description

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.
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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice