Recurrent and/or metastatic squamous cell carcinoma of the head and neck
Conditions
Interventions
Paclitaxel 100 mg/m^2/day1,8, every 3 weeks. CBDCA AUC 2.5/day1,8, every 3 weeks, up to 6cycle. Cetuximab loading dose 400 mg/m^2, followed by 250 mg/m^2, weekly, until disease progression.
Sponsors
CSPOR-HN 02 executive committee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or Cytological proven squamous cell carcinoma of the head and neck 2) Primary lesion located at the oral cavity, oropharynx, hypopharynx, or larynx 3) Measurable disease according to RECIST ver1.1 4) Not amenable for local treatment for recurrent/ metastatic disease 5) ECOG performance status 0 or 1 6) Age >=20 at the time of informed consent 7) Adequate organ function 8) HBs Ag negative 9) Life expectancy of greater than 3 months 10) Women of child-bearing potential and men who are able to father a child agree with using adequate contraception 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Prior systemic chemotherapy except if given as a definitive multimodal treatment included induction chemotherapy, concurrent chemoradiotherapy and postoperative adjuvant chemoradiotherapy, which was completed more than 6 month prior to registration. 2)Prior surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before registration 3) Current other synchronous primary double cancers and metachronous double cancers unless free of disease for at least five years (excluding superficial cancer that will be cured by endoscopic mucosal resection) 4) Symptomatic brain metastasis 5) Severe myelosuppression or infection 6) Pulmonary fibrosis, acute lung injury or Intestinal pneumonia 7) Clinically relevant comorbidity included heart failure, renal failure, liver failure, uncontrolled hypertension or uncontrolled diabetes mellitus 8) History of severe hypersensitivity 9) Known hypersensitivity against any components of the trial treatment including excepients 10) Pregnancy or breast feeding 11) Other concomitant anticancer therapies 12) Current administration of disulfiram, Cyanamide, Carmofur or procarbazine hydrochloride 13) Previous treatment with cetuximab or monoclonal antibody 14) Other significant disease that in the investigator's opinion would exclude the subject from the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, treatment completion rate, progression-free survival, overall survival, clinical benefit rate | — |
Countries
Japan
Contacts
Public ContactAkira Yamao
Public health research foundation Executive office of Comprehensive Support Project for Oncology Research
Outcome results
None listed