Open-label, randomized, controlled Phase I/IIstudy of cilengitide to evaluate the safety andefficacy of the combination of different regimensof cilengitide added to cisplatin, 5-FU, andcetuximab in subjects with recurrent/metastaticsquamous cell cancer of the head and neck(?ADVANTAGE?) - ADVANTAGE

Active, not recruiting

• Conditions: Recurrent/metastatic squamous cell cancer of the head and neck; MedDRA version: 12.0Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck

• Registration Number: EUCTR2008-000615-15-IT
• Lead Sponsor: MERCK KGAA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-28
• Last Update Posted: 11 November 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

1-Histologically or cytologically confirmed diagnosis of SCCHN.
2- At least 1 measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI).
3- Karnofsky performance status (KPS) of ≥70/ Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 at study entry
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

1. Prior systemic chemotherapy, except if given as part of a multimodal treatment for
locally advanced disease which was completed more than 6 months prior to study
entry.
2. Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study
entry.
3. Nasopharyngeal carcinoma.
4.Documented or symptomatic brain or leptomeningeal metastasis.
5.Previous treatment with EGFR targeting therapy or signal transduction inhibitors.

Study & Design

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