Status:
COMPLETED
Platinum-Cetuximab Combined With Docetaxel or With 5FU in Patients With Recurrent/Metastatic HNSCC
Lead Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Collaborating Sponsors:
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
AIO-Studien-gGmbH
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18-71 years
Phase:
PHASE2
Brief 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 metas...
Detailed Description
The EXTREME regimen, i.e. cetuximab added to platinum (100 mg/m² every 3 weeks ) and 5FU (96h continuous infusion at 1000 mg/m²/day every 3 weeks) during 6 cycles of treatment and continued as mainten...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
541 Patients enrolled
Trial Details
Trial ID
NCT02268695
Start Date
October 10 2014
End Date
December 31 2021
Last Update
August 23 2022
Active Locations (17)
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1
Institut Sainte Catherine
Avignon, France, 84082
2
Centre Hospitalier de la Dracénie
Draguignan, France
3
Centre Médical de Forcilles
Férolles-Attilly, France, 77150
4
Clinique des Ormeaux
Le Havre, France, 76600