Phase II trial of Combination with Paclitaxel, Carboplatin and Cetuximab (PCE) as a first line treatment in patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck - Phase II trial of Combination with Paclitaxel, Carboplatin and Cetuximab (PCE) as a first line treatment in patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (CSPOR-HN 02)

CSPOR-HN 02 executive committee0 sites45 target enrollmentApril 16, 2013

Overview

No summary available.

Registry

who.int

Start Date

April 16, 2013

End Date

October 31, 2015

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

CSPOR-HN 02 executive committee

•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.