Phase II-Studie zur Erfassung der Effektivität einer wöchentlich verabreichten Docetaxel-Carboplatin/Cisplatin-Cetuximab-Kombination (DCC) bei fortgeschrittenen Plattenepithelkarzinomen des Oropharynx und der Mundhöhle

• Conditions: patients with advanced squamaous cell carcinom on oropharynx or oral cavity; MedDRA version: 12.1Level: LLTClassification code 10041857Term: Squamous cell carcinoma of the oral cavity; MedDRA version: 12.1Level: LLTClassification code 10031112Term: Oropharyngeal squamous cell carcinoma

• Registration Number: EUCTR2007-007034-18-DE
• Lead Sponsor: Charité Universitätsmedizin Berlin - CVK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-15
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- histologically confirmed relapse or metastasis of an advanced squamaous cell carcinoma in oropharynx or oral cavity
- patients with relapse and/or metastasis of the head and neck for whom a local therapy is not indicated
- patients with at least one measurable lesion according RECIST-criteria version 1.0
- ECOG performace status 0 or 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- radiotherapy within the last 6 months before screening
- systemic chemotherapy apart from radiochemotherapy for local advanced tumor
- therapy with antibodies or protein kinase inhibitors
- any prior or existing malignancies except SCCHN. Except for basal squamous scell skin cancer and adequately treated carcinoma in situ of the cervix

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified