Recurrent/metastatic head and neck squamous cell carcinoma MedDRA version: 14.1 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ERBITUX*INFUS 1FL 50ML 2MG/ML
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923564
Current Sponsor code: NA
Other descriptive nam
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed written informed consent - Male or female > 18 years of age - Histologically or cytologically confirmed diagnosis of SCCHN - Confirmed RM SCCHN (oral cavity, oropharynx, larynx, hypopharynx, paranasal sinus), not suitable for local therapy - At least one measurable lesion according to the RECIST criteria (> 10 mm with spiral CT) must be present - At least 6 months since completion of systemic chemotherapy or biologic therapy - ECOG Performance Status 0-1 - Adequate bone marrow function: neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, haemoglobin > 9 g/dL - Adequate liver function: bilirubin 60 mL/min - Tumor tissue of primary or recurrent disease available - Blood samples collected before and during the study available - If of childbearing potential, willingness to use effective contraceptive method (Pearl Index =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: No previous chemotherapy or biological therapy for recurrent/metastatic disease - Nasopharyngeal Tumor - Surgery (excluding prior diagnostic biopsy, tracheostomy or gastrostomy), or irradiation within 4 weeks before study entry - Other serious illnesses or medical conditions: - Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months; - Significant neurologic or psychiatric disorders including dementia or seizures; - Active uncontrolled infection (requiring IV antibiotics) or known HIV positivity and active tubercolosis; - Active disseminated intravascular coagulation; - Other serious underlying medical conditions which could impair the ability of the patient to participate in the study; - Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC V 4.0) grade =2 and/or ototoxicity grade =2, except if due to trauma or mechanical impairment due to tumor mass; - Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease; - Having participated in another clinical trial or having received any investigational agent in the preceding 30 days before study entry; - Chronic systemic immunosuppressive therapy that can not be interrupted during treatment study; - Known allergic/hypersensitivity reaction to any of the components of the treatment; - Pregnancy (absence confirmed by serum/urine beta HCG) or breast-feeding; - Other active malignancy within 5 years, with exception of a history of a previous, adequately treated, basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix; - Legal incapacity or limited legal capacity; - Medical, psychological or socio-geographical condition or situation which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: progression-free survival;Secondary Objective: Overall Survival Response Rate Toxicity profile Pharmacogenomic study of predictive and prognostic markers in tumor tissue Pharmacodynamic study of predictive and prognostic serum markers;Primary end point(s): PFS;Timepoint(s) of evaluation of this end point: 6-12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Survival Response Rate Toxicity profile Pharmacogenomic study of predictive and prognostic markers in tumor tissue Pharmacodynamic study of predictive and prognostic serum markers;Timepoint(s) of evaluation of this end point: 6-12 mesi | — |
Countries
Italy
Contacts
Public ContactS.S. Tratt. Med. Tumori Testa-Collo
Fondazione IRCCS Istituto Nazionale Tumori
Outcome results
None listed