Platinum-Cetuximab Combined With Docetaxel or With 5FU in Patients With Recurrent/Metastatic HNSCC

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx) versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while the other half will be treated by EXTREME regimen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
• Collaborators: AIO-Studien-gGmbH; Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
• Treatments: Cetuximab; Cisplatin; Docetaxel; Lenograstim; Sargramostim

Criteria

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.

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

• Malignancies within 5 years prior to randomization, with the exception of adequately treated basal or squamous cell 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