Cetuximab, Paclitaxel, and Carboplatin for Operable Head and Neck Squamous Cancer
Cetuximab
+ Carboplatin
+ Paclitaxel
Head and Neck Neoplasms
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
Study start date: January 6, 2005
Actual date on which the first participant was enrolled.This clinical trial aims to evaluate the effectiveness of a specific treatment combination for operable head and neck squamous cell cancer, a type of cancer affecting the tissues lining the mouth, nose, and throat. The trial focuses on patients with stage III or IV of the disease. The main goal is to improve the 1-year event-free survival rate, which means the proportion of patients who do not experience disease progression, need for surgery at the primary site, or death within a year. The treatment regimen includes a mix of cetuximab, paclitaxel, and carboplatin, along with radiation therapy. This study is important as it could potentially enhance the care and treatment outcomes for patients with this form of cancer. The trial proceeds in three stages: induction therapy, chemoradiotherapy, and maintenance therapy. During the induction therapy, participants receive cetuximab, paclitaxel, and carboplatin for six weeks. This is followed by a biopsy and evaluation. In the chemoradiotherapy stage, participants receive the same drugs along with radiation therapy. Depending on the response to treatment, some participants may receive additional chemoradiotherapy or undergo surgery. The final stage is maintenance therapy, where participants receive cetuximab once a week for six months. Throughout the study, participants are monitored regularly to assess the treatment's effectiveness and any potential side effects. The study measures the response of the tumor, disease-free survival, overall survival, and the impact on specific biological pathways.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.74 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
INCLUSION CRITERIA: * Locally advanced (Stage III/IV), but potentially operable squamous cancer of the head and neck (exclude nasopharynx). Primary site biopsies must have had proven for cancer, nodal status, confirmed by clinical and pathologic exam with fine needle aspiration cytology recommended. * ECOG performance status 0 - 1. * Adequate laboratory index (ANC \> 1500/mm3, platelets \> 100,000/mm3, creatinine 1.5mg/dl, bilirubin 1.5mg/dl) completed within 4 weeks prior to registration. * Surgical resectability: * Included patients with operative stage III/IV disease, high likelihood of achieving R0 resection (complete resection with clean margins indicating NO residual cancer). * Measurable disease, biopsy proven at primary site. Patients with clinically palpable cervical nodes were to have evaluation by CT scan and fine needle aspiration (FNA) confirmation of disease. Patients with non-palpable neck nodes had CT determination. In the absence of clinically palpable nodes, radiographic findings were acceptable. * At least one objective measurable disease parameter in the primary site or neck. * Baseline measurements or evaluations must have had obtained within 4 weeks prior to registration in the study. * Age \> 18 years. * Women of childbearing potential and sexually active males were strongly advised to use an accepted and effective method of contraception. * Original diagnostic materials must have had submitted for baseline EGFR assessment by the designated laboratory. EXCLUSION CRITERIA: * Patients with fixed nodal metastases to spine or carotid artery, patients with invasion of root of tongue, pharyngeal muscle, post pharynx, or vertebral fascia or invasion of laryngeal cartilage into strap muscles or tracheal (\>1cm) invasion. * Prior chemotherapy, surgery radiation or immunotherapy for head and neck cancer. * Prior malignancies except in situ lobular breast carcinoma, in situ cervical carcinoma, basal cell cancers or previously excised and controlled cutaneous squamous cancer (\<200 mm thick) were permitted. * Significant history of cardiac disease i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias. * Prior anti-epidermal growth factor receptor antibody therapy or therapy with a tyrosine kinase inhibitor including inhibitors targeting EGFR pathway. * Prior chimerized or murine monoclonal antibody therapy or known allergy to murine proteins or cremophor EL. * Pregnant or breast-feeding women. All females of childbearing potential must have had a blood test or urine study within 72 hours of study entry and must not have had started therapy until 5 days after registration was over to rule out pregnancy.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives