Cetuximab and Cisplatin with or without Paclitaxel in recurrent/metastatic head and neck cancer
- Conditions
- Recurrent/metastatic head and neck squamous cell carcinomaMedDRA version: 14.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-002564-24-IT
- Lead Sponsor
- ISTITUTO NAZIONALE PER LA CURA TUMORI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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 < 2 X upper normal limit (except from known medical reason not interfering with liver function, such as Gilbert disease), SGOT, SGPT, AP, GGT < 3 x ULN
- Adequate renal function: calculated or analysed creatinine clearance > 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 < 1; e.g. oral contraceptive (pill), hormone spiral, hormone implant, transdermal patch, a combination of two barrier methods (condom and diaphragm), sterilisation, sexual abstinence) for the study duration and 2 months post-dosing.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: progression-free survival;Secondary Objective: Overall Survival<br>Response Rate<br>Toxicity profile<br>Pharmacogenomic study of predictive and prognostic markers in tumor tissue<br>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 Outcome Measures
Name Time Method Secondary end point(s): Overall Survival<br>Response Rate<br>Toxicity profile<br>Pharmacogenomic study of predictive and prognostic markers in tumor tissue<br>Pharmacodynamic study of predictive and prognostic serum markers;Timepoint(s) of evaluation of this end point: 6-12 mesi