Head and Neck Cancer Clinical Trial
Official title:
A Phase II Multi-Center Study of Concomitant Cetuximab and Cisplatin With Re-Irradiation Using Intensity-Modulated Radiotherapy in Patients With Recurrent Squamous Cell Carcinoma of the Head-and-Neck
Verified date | November 2018 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as
cisplatin, 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 cetuximab and cisplatin together with radiation therapy may kill more
tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together
with radiation therapy works in treating patients with recurrent head and neck cancer.
Status | Completed |
Enrollment | 37 |
Est. completion date | May 2016 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract - Recurrent disease or second primary SCC - Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence) - Majority (= 75%) of the recurrent tumor must be in areas previously irradiated to = 45 Gy - More than one recurrence allowed provided the first recurrence occurred > 6 months after the completion of prior radiotherapy - Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension) - No signs of carotid exposure - No primary nasopharyngeal or salivary gland tumor - Equivocal pulmonary nodes on chest CT scan allowed provided they are < 1 cm, cannot be safely biopsied, or are negative on PET scan - No distant metastasis PATIENT CHARACTERISTICS: - Karnofsky performance status 70-100% - ANC = 2,000/mm^3 - Platelet count = 100,000/mm^3 - Hemoglobin = 8.0 g/dL (transfusion or other intervention allowed) - Bilirubin < 1.5 mg/dL - AST or ALT < 2 times upper limit of normal - Creatinine clearance = 50 mL/min - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to submit prior radiotherapy records to assure that the spinal cord tolerance is not exceeded - No active cardiac disease, including any of the following: - Unstable angina - Uncontrolled hypertension - Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty) - Uncontrolled arrhythmia - Congestive heart failure - At least 3 heart-related hospitalizations within the past year - No severe chronic obstructive pulmonary disease requiring = 3 hospitalizations within the past year - No concurrent medical illness that would impair patient tolerance to therapy or limit survival - No other invasive malignancy within the past 2 years - No pre-existing peripheral sensory neuropathy = grade 2 - No prior severe infusion reaction to a monoclonal antibody - No prisoners or individuals who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Recovered from prior surgery - Prior cisplatin and cetuximab allowed - At least 6 months since prior radiotherapy or chemotherapy - No prior radiotherapy > 75 Gy - No prior chemotherapy for recurrent head and neck cancer - Prior chemotherapy as a component of the primary treatment allowed - No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and neck cancer - Patients with a new primary head and neck cancer whose prior primary head and neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy are eligible provided it has been > 6 months since treatment |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | Baylor Research Institute | Dallas | Texas |
United States | University of Texas Southwestern Medical Center - Dallas | Dallas | Texas |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival (PFS) | The 2-year PFS was measured from the date of enrollment to the first occurrence of new metastatic lesions, objective tumor progression, or death. The combination of cisplatin and cetuximab concurrent with radiation therapy for head and neck cancer has shown to have a favorable PFS. Patients were followed until death or from 7.5 months to 63.6 months (median 25.6 months) in those alive at last evaluation. | 2 year from the date of enrollment | |
Secondary | Number of Participants With Acute and Late Toxicities | Incidence rate of acute and late toxicities of grade 3 or higher was measured after each treatment cycle was over. The most common late toxicities defined as toxicity occurring more than 90 days after treatment included laryngeal edema and xerostomia. | 6 months within the end of treatment |
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 |