Phase II multicenter trial of platinum-cetuximab combined with docetaxel or with 5FU for Japanese patients with recurrent/metastatic squamous cell carcinoma of the head and neck.
- Conditions
- recurrent/metastatic squamous cell carcinoma of the head and neck
- Registration Number
- JPRN-UMIN000025436
- Lead Sponsor
- Clinical Research Support Center Kyushu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 180
Not provided
1) Prior systemic chemotherapy (expect as part of a multimodal therapy for locally advaneced disease > 6 months before the trial entry) 2) Prior dose of cisplatin > 300 mg/m2 3) Prior surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before registration 4) Simultaneous or metachronous (within 3 years) double cancers (excluding superficial cancer that will be cured by endoscopic mucosal resection) 5) Symptomatic brain metastasis 6) Severe myelosuppression or infections 7) Pulmonary fibrosis, acute lung injury or Intestinal pneumonia 8) Severe and uncontrolled complication (heart failure, pulmonary fibrosis, renal failure, hepatic failure, uncontrolle diabetes mellitus or uncontrolled hypertension) 9) Known hypersensitivity against any components of the trial treatment including excepients 10) Pregnancy or breast feeding 11) Receiving other concomitant anti tumor therapy 12) Previous treatment with cetuximab or monoclonal antibody 13) Positive HBs antigen 14) Decision of ineligibility by a physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method