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A Phase II Study of Erlotinib and Radiation Therapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck


Phase 2
18 Years
70 Years
Not Enrolling
Both
Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Verrucous Carcinoma of the Larynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Verrucous Carcinoma of the Larynx, Stage IV Verrucous Carcinoma of the Oral Cavity

Thank you

Trial Information

A Phase II Study of Erlotinib and Radiation Therapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck


PRIMARY OBJECTIVES:I. To determine the time to progression of the combination of the EGFR
inhibitor erlotinib and radiation therapy. SECONDARY OBJECTIVES:I. To determine objective
response rate, locoregional control rate, duration of response, patterns of failure, overall
survival, toxicities and quality of life outcomes of the combination of erlotinib and
concurrent radiation therapy.II. To determine the pharmacokinetic profile of erlotinib.
Additional analyses of the pharmacokinetic data on patients receiving daily erlotinib
treatment via their feeding tube will be conducted. III. To determine the effect of
treatment and dose of treatment on biologic correlates in tumor tissue and/or surrounding
mucosa, EGFR expression and phosphorylation status, serum markers of angiogenic activity
VEGF, sVEGFR-2, sKIT, ICAM, PDGF, fluorescence in situ hybridization (FISH) for ERBB2 for
gene amplification, DNA-sequencing of EGFR and ERBB2 genes from DNA extracted from
pretreatment biopsy material for mutation screening, gene expression profiling on
pre-treatment biopsy material to identify predictors of response to treatment, apoptosis
(TUNEL assay), Ki67 (nuclear proliferation antigen)IV. To determine the utility of the
comprehensive geriatric assessment, in predicting tolerance to treatment in patients >= 65
years included in this trial. OUTLINE: Patients receive erlotinib hydrochloride orally or
via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of
radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once
daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease
progression or unacceptable toxicity.After completion of study treatment, patients are
followed up at 6 months, every 3 months for 2 years, and then every 6 months for 2 years.


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed locally advanced (stage
III or IV) squamous cell carcinoma of the head and neck without distant metastatic
disease, who are not candidates or have declined definitive surgical resection or for
administration of standard chemotherapy during radiation therapy because of any of
the following reasons: advanced age (>= 70 years); poor ECOG performance status (2 or
3); significant comorbidities, as reflected by a Charlson comorbidity index score of
>= 3; abnormal hematopoietic, hepatic or renal function; patient's decision after
applicable standard treatment options have been offered and declined by patient

- No prior chemotherapy, radiation therapy, or investigational antitumor drug

- Measurable disease within 4 weeks prior to registration according to the recommended
RECIST response criteria

- Life expectancy of greater than 12 weeks

- Patients must have normal hepatic function or well compensated liver disease as
defined by the Child-Pugh classification of severity of liver disease; patients with
hepatic impairment (total bilirubin greater than upper limit of normal [ULN] or
well-compensated disease [Child-Pugh class A] enrolled in the trial will be closely
monitored, especially those with total bilirubin > 3 times ULN; dosage modifications
(therapy interruption or discontinuation) may be necessary for severe changes in
liver function; patient management will follow the FDA-approved labeling
recommendations

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control) prior to study entry and for the
duration of study participation

- Men and women of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months thereafter

- Women of childbearing potential must have a negative pregnancy test; should a woman
become pregnant or suspect she is pregnant while participating in this study, she
should inform her treating physician immediately

- Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

- All histologies other than squamous cell carcinoma

- Salivary gland paranasal sinus and nasopharyngeal squamous cell carcinoma

- Patients who have had prior chemotherapy or radiotherapy

- Patients with metastatic disease

- Patients with ECOG performance status of 4

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to ERLOTINIB

- Patients with history of any other malignancy (except squamous cell or basal cell
cancer of the skin or CIS of cervix) are ineligible unless a period of 5 years has
elapsed since treatment of the previous cancer and the patient is currently
disease-free from the previous cancer

- Patients may not be receiving any other investigational agent

- Pregnant women; breastfeeding should be discontinued

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to disease progression

Outcome Description:

The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started.

Outcome Time Frame:

for 5 years following treatment

Safety Issue:

No

Principal Investigator

Panayiotis Savvides

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CASE2309

NCT ID:

NCT01192815

Start Date:

January 2011

Completion Date:

October 2012

Related Keywords:

  • Stage III Squamous Cell Carcinoma of the Hypopharynx
  • Stage III Squamous Cell Carcinoma of the Larynx
  • Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage III Squamous Cell Carcinoma of the Oropharynx
  • Stage III Verrucous Carcinoma of the Larynx
  • Stage III Verrucous Carcinoma of the Oral Cavity
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IV Squamous Cell Carcinoma of the Nasopharynx
  • Stage IV Squamous Cell Carcinoma of the Oropharynx
  • Stage IV Verrucous Carcinoma of the Larynx
  • Stage IV Verrucous Carcinoma of the Oral Cavity
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Diseases
  • Carcinoma, Verrucous
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Oropharyngeal Neoplasms
  • Nasopharyngeal Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065