Inoperable squamous cell carcinoma of the head and neck.
Conditions
Interventions
Trade Name: Erbitux
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923564
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: not less then
Sponsors
Institute of Oncology Ljubljana
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Squamous cell carcinoma, histologically proven. - Tumor site: oral cavity, oropharynx, hypopharynx, or larynx. - Locally and/or regionally inoperable tumors (UICC TNM stages IVa or IVb), without distant metastases (M0-stage); criteria for inoperability: --> Technical unresectability, --> Tumor fixation to the clavicle, base of skull or the cervical vertebrae, --> Involvement of the nasopharynx or carotid artery. - Declaration of the inoperability of the patient given by a head and neck surgeon and radiation oncologist at the multidisciplinary tumor conference. - Male or female =18 years of age. - Expected survival > 6 months. - Presence of at least one bidimensionally measurable index lesion. - Effective contraception for both male and female subjects if risk of conception exists. - WHO performance status 0-2 - Laboratory parameters: --> hemoglobin =100 g/L --> leukocyte count > 3,5×109/L, absolute neutrophil count =1,5×109/L --> platelet count > 100×109/L --> total bilirubin transaminases (ALT, AST) creatinine clearance =55 ml/minute. - Signed written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Metastatic disease. - Squamous cell carcinoma of the nasopharynx and nasal cavity and paranasal sinuses. - ChT or XRT ineligibility: --> Unstable cardiac disease or any other medical condition likely to compromise the safe delivery of ChT or XRT; --> Clinically evident hearing impairment; --> Pre-existing motor or sensory neurotoxicity grade = 2 according to the CTCAE v3.0. - Any kind of previous therpay for SCCHN (excluding diagnostic biopsy). - Previous administration of EGFR pathway-tergeting therapy. - Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy which is not part of the study protocol. - Participation in another clinical trial within 30 days prior to study entry. - Pregnancy or breast feeding. - History of severe acute pulmonary disease. - Any investigational agent within past 30 days. - Other previous malignancy within 5 years, with exception of a history of a previously adequately treated basal call carcinoma of the skin or pre-invasive carcinoma of the cervix. - Known drug abuse / severe alcohol abuse. - Legal incapacity or limited legal capacity. - Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent. - Active, uncontrolled infection. - Other medical condition or other therapy that in the opinion of the investigator precludes the safe administration of the planned ChT and XRT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Locoregional control at 2 years.;Secondary Objective: - To determine feasibility (toxicity profile) of the proposed regimen. - Complete response rate after induction chemotherapy. - Complete response rate 14-16 weeks after completion of ChRT and Erbitux. - Disease free survival at 2 years. - Overall survival at 2 years. - Late toxicity including thyroid function.;Primary end point(s): Locoregional control at 2 years. | — |
Countries
Slovenia
Outcome results
None listed