- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01192815
Erlotinib Hydrochloride and Radiation Therapy in Stage III-IV Squamous Cell Cancer of the Head and Neck
A Phase II Study of Erlotinib and Radiation Therapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck
Study Overview
Status
Conditions
- 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
Intervention / Treatment
- Other: laboratory biomarker analysis
- Other: pharmacogenomic studies
- Other: pharmacological study
- Other: gene expression analysis
- Drug: erlotinib hydrochloride
- Radiation: intensity-modulated radiation therapy
- Radiation: 3-dimensional conformal radiation therapy
- Other: biopsy
- Other: questionnaire administration
- Other: enzyme-linked immunosorbent assay
- Other: polymorphism analysis
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106
- 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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm I
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.
|
Optional correlative studies
Optional correlative studies
Other Names:
Optional correlative studies
Other Names:
Correlative studies
Given orally or via gastronomy tube
Other Names:
IMRT will be given in 35 fractions over 7 weeks.
The primary tumor and involved nodes (PTV70) will receive 2 Gy per fractions, intermediate-risk areas (PTV63) will receive 1.8 Gy per fractions, and subclinical disease sites (PTV56) will receive 1.6 Gy perfraction.
The total doses will thus be 70 Gy, 63 Gy and 56 Gy, respectively.
Other Names:
The initial target volume encompassing the gross and subclinical disease sites will receive 2.0 Gy per fraction, five fractions a week to 54 Gy in 27 fractions in 5.4 weeks. The boost volume covering gross tumor and clinically/radiologically involved nodes will receive boost irradiation for additional 16 Gy at 2.0 Gy. The primary tumor and clinically/radiologically-involved nodes will thus receive 70 Gy in 35 fractions over 7 weeks, and uninvolved upper neck nodes will receive an elective dose of 54 Gy in 5.4 weeks. The uninvolved lower neck nodes will receive 2.0 Gy per fraction at 3-cm depth to a total dose of 50 Gy in 25 fractions in 5.0 weeks through a matching AP or AP/PA lower neck field.
Other Names:
Optional correlative studies
Other Names:
Optional ancillary studies
Optional correlative studies
Other Names:
Optional correlative studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Disease Progression
Time Frame: 1 year and 10 months following study start
|
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. Disease progression free survival (PFS) is measured from start of treatment to the date of disease progression or protocol-designated outcome, whichever occurs first and censored at the date of last followed for those survivors without disease progression Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Measured via Conventional CT and MRI |
1 year and 10 months following study start
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: 1 year and 10 months following study start
|
Number of patients with complete response, partial response, stable disease, or progressive disease.
Assessed via Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured via conventional CT and MRI
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1 year and 10 months following study start
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Patterns of Failure
Time Frame: 5 yrs following treatment
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5 yrs following treatment
|
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Toxicities, Number of Persons With Adverse Events
Time Frame: up to 2 yrs after treatment
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Number of participants who experienced adverse events (AE's) and serious adverse events (SAE's) during the course of the trial according to CTCAE (4.0)
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up to 2 yrs after treatment
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Quality of Life Assessment as Measured by Functional Assessment of Cancer Therapy (FACT-G) Test
Time Frame: after treatment at 6 mos
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Quality of Life (QOL) measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL.
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after treatment at 6 mos
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Locoregional Control Rate
Time Frame: 5 yrs following treatment
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5 yrs following treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic Data
Time Frame: pre-treatment then weekly
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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.
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pre-treatment then weekly
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Lab Correlates
Time Frame: 2 yrs post concurrent chemo-radiation therapy
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Determine the effect of treatment and dose of treatment on biologic correlates in tumor tissue and/or surrounding mucosa.
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2 yrs post concurrent chemo-radiation therapy
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Collaborators and Investigators
Sponsor
Collaborators
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 (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Head and Neck Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Neoplasms, Squamous Cell
- Oropharyngeal Neoplasms
- Laryngeal Neoplasms
- Laryngeal Diseases
- Carcinoma, Verrucous
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
Other Study ID Numbers
- CASE2309
- NCI-2010-01885 (OTHER: NCI/CTRP)
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.
Clinical Trials on Stage III Squamous Cell Carcinoma of the Hypopharynx
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Arbeitsgemeinschaft medikamentoese TumortherapieMedical University of GrazTerminatedLocally Advanced Malignant Neoplasm | Squamous Cell Carcinoma of the Hypopharynx Stage III | Squamous Cell Carcinoma of the Hypopharynx Stage IV | Squamous Cell Carcinoma of the Oral Cavity Stage III | Squamous Cell Carcinoma of the Oral Cavity Stage IV | Laryngeal Squamous Cell Carcinoma Stage... and other conditionsAustria
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Arbeitsgemeinschaft medikamentoese TumortherapieCompletedSquamous Cell Carcinoma of the Hypopharynx Stage III | Squamous Cell Carcinoma of the Hypopharynx Stage IV | Squamous Cell Carcinoma of the Larynx Stage III | Squamous Cell Carcinoma of the Larynx Stage IV | Squamous Cell Carcinoma of the Oropharynx Stage III | Squamous Cell Carcinoma of the... and other conditionsAustria
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