A Phase II Study of Evaluation of Cetuximab (Erbitux) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck.
Investigator:
Mohan Suntharalingam, M.D.
Summary:
This is a phase II study for the management of patients with advanced locoregional squamous cell carcinomas of the head and neck looking at combining cetuximab, paclitaxel, carboplatin, and radiotherapy in an effort to enhance locoregional disease control. Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy. Chemotherapy will be given every week for a total of 8 weeks. Paclitaxel will be given at a dose of 40 mg/m2 as a 1 hour infusion dose followed by cetuximab and then carboplatin AUC = 2/week.
The initial dose of cetuximab is 400 mg/m2 IV on day 1, followed by weekly infusions at 250 mg/m2 IV.
Primary Objective:
To evaluate whether the addition of Cetuximab (C225) in combination with chemotherapy and radiation can cause an enhanced anti-tumor effect resulting in improving local regional control of patients with locally advanced, unresectable squamous cell carcinoma of head and neck. (SCCHN).
Disease site:
Head and Neck
Disease stage:
T4 N0-3, A, B, C, T3 N1-3 A, B,C, any T, N3 A,B,C
Condition:
Histologically proved locally advanced squamous cell carcinoma of the head and neck of all primary sites.
Intervention:
Chemotherapy + XRT + Cetuximab
Phase:
II
Study number:
GCC 0442
Eligibility*
(inclusion criteria)
Histologically proved locally advanced squamous cell carcinoma of the head and neck of all primary sites.
The following TNM stages by sites will be eligible.
Oral cavity, Pharynx, Larynx, Nasopharynx, paranasal sinuses
T4 N0-3, A, B, C, T3 N1-3 A, B,C, any T, N3 A,B,C Unknown primary
Tx, N3 A,B,C Note: Only clearly unresectable T4 N0 lesions are eligible for
study provided the reasons for unresectability are due to extensive anatomic involvement and are outlined by the surgeon.
Patients must have signed an approved informed consent.
Patients with tumor tissue available for assessment of EGFR status by IHC.
Patients with Performance Status 0-2.
No evidence of distant metastatic disease.
No previous radiation therapy.
No previous chemotherapy.
Patients, 18 years and older, must either be not of child bearing potential or have a negative pregnancy test
within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically
sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
Adequate renal & bone marrow function determined by the following laboratory parameters.
Bone marrow function: WBC ³ 3500/ul, Platelet count ³ 100,000/ul, Hemoglobin ³ 9.0 g/dl , BUN less than or equal
to 20 mg/dl and Serum creatinine £ 2.0 mg/dl ,Total bilirubin <2.0 mg/Dl, AST/ALT
< 3 times the ULN, Creatinine Clearance ³ 50 cc/min
Evidence of measurable disease.
No evidence of concomitant malignancy except for non-melanomatous skin cancer (controlled or controllable) or
carcinoma in situ of the cervix
No concomitant life threatening or uncontrolled serious medical illness such as end stage congestive
heart failure cardiac arrythmia, liver disease and organic brain syndrome.
(exclusion criteria)
Acute hepatitis or known HIV.
Active or uncontrolled infection
Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure or acute CHF within the past 6 months, and cardiomyopathy with decreased ejection fraction
Prior therapy which specifically and directly targets the EGFR pathway
Prior severe infusion reaction to a monoclonal antibody
Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s)
Requirement for concurrent use of pilocarpine
Pregnant or lactating females or females of child bearing potential not employing adequate contraception
Preexisting clinically significant neuropathy
Patients currently taking anti-arrhythmics are excluded
Patients with loco-regional recurrences from any site with no prior radiation therapy and not amenable for salvage surgery are not eligible for study.
Contact Person
Ritesh Kataria, MS 410-328-8018
* Note: This study may include eligibility criteria that are not listed here. For more information about the study or to find out if you are eligible, call 1-800-888-8823.
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