Randomized, controlled trial of Platinum-Cetuximab combined either with Docetaxel (TPEx) or with 5FU (Extreme) in patients with recurrent/metastatic squamous cell cancer of the head and neck

Phase 1

• Conditions: recurrent or metastatic head and neck squamous cell carcinoma; MedDRA version: 19.1Level: PTClassification 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: EUCTR2014-000048-14-DE
• Lead Sponsor: GORTEC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-26
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Histologically confirmed diagnosis squamous cell carcinoma of head and neck: oral cavity, oropharynx, hypopharynx, larynx (histological confirmation is mandatory at least for initial diagnosis)
• Recurrence and/or metastatic disease not suitable for local therapy
• At least one measurable lesion (RECIST) by CT or MRI
• PS < 2
• Age = 18 years and < 71 years
• Clearance of creatinine > 60ml/mn (MDRD)
• Haematological function as follows: absolute neutrophil count > 1.5 x 109/l, platelet > 100 x 109/l, hemoglobin = 9.5 g/dl
• Hepatic function as followed: bilirubin = Upper limit of normal (ULN); SGOT/SGPT < 1.5 ULN; AP < 2.5 ULN
• Estimated life expectancy > 12 weeks
• Informed Consent Form signed
• Affiliation to an health insurance
• Negative pregnancy test in women of childbearing potential within 14 days prior to treatment initiation (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization). Both men and women (of childbearing potential) who are sexually active must use adequate contraception, during and for at least 6 months post-treatment.
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 540
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with nasopharyngeal cancer, paranasal sinus cancer or unknown primary
• Prior systemic chemotherapy for the head and neck carcinoma, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry
• Surgery (excluding diagnostic biopsy) or radiotherapy within 6 weeks before study entry
• Contra-indication to receive cisplatin
• Known dihydropyrimidine dehydrogenase (DPD) deficiency
• Administration of prophylactic phenytoin
• Recent or planed yellow fever vaccination
• Prior dose of cisplatin > 300 mg/m² (a patient who received prior RT + 3 cycles of cisplatin or 3 cycles induction TPF, i.e. total dose of cisplatin = 300 mg/m², for locally advanced primary HN cancer can be included)
• Prior anti-EGFR treatment received less than 12 months before enrolment in the trial
• Known hypersensitivity reaction to 5FU, cisplatin, carboplatin, docetaxel or cetuximab
• Documented or symptomatic brain or leptomeningeal metastasis
• 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
• Other malignancies within 5 years prior to randomization, with the exception of adequately treated basal skin cancer and carcinoma in situ of the cervix.
• Active infection (infection requiring IV antibiotics), including active tuberculosis and known and declared human immunodeficiency virus (HIV).
• Significant disease which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial.
• Any social, personal, medical and/or psychologic factor(s) that could interfere with the observance of the patient to the protocol and/or the follow-up and/or the signature of the informed consent.
• Pregnant or breast feeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified