Head and Neck Cancer Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free-survival | 3 yrs after treatment | No | |
Primary | Time to progression | 3 yrs after treatment | No | |
Secondary | Response rate (complete response, partial response, stable disease, and disease progression) | 3 yrs after treatment | No | |
Secondary | Overall survival | 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. | No | |
Secondary | Toxicities | evaluated every 2 weeks | Yes | |
Secondary | Predictive values of EGFR/TGF-a, VEGF | collection at baseline and periodically during study. | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |