Open-label, randomized, controlled Phase I/II study of cilengitide to evaluate the safety and efficacy of the combination of different regimens of cilengitide added to cisplatin, 5-FU, and cetuximab in subjects with recurrent/metastatic squamous cell cancer of the head and neck. - ADVANTAGE
- Conditions
- Recurrent/metastatic squamous cell cancer of the head and neck.MedDRA version: 9.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck
- Registration Number
- EUCTR2008-000615-15-HU
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 177
1. Histologically or cytologically confirmed diagnosis of SCCHN.
2. At least one measurable lesion either by CT scan or MRI.
3. KPS of =70/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
1. Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanceddisease 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 epidermal growth factor receptor (EGFR) targeting therapy or signal transduction inhibitors.
6. Left ventricular ejection fraction < 40%
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Progression Free Survival ;Secondary Objective: - safety and tolerability of the combination of cilengitide with cetuximab,<br>cisplatin, and 5-FU in the overall study population.<br>- overall survival time<br>- best overall response<br>- disease control<br>- duration of response<br>- time to treatment failure.<br>- pharmacokinetic (PK) profiles of cilengitide and cetuximab when cilengitide is given in combination with cetuximab and cisplatin.;Primary end point(s): Progression free survival time
- Secondary Outcome Measures
Name Time Method