The purpose of this open-label, randomized, controlled Phase I/II study of the anti-integrin cilengitide is 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 SCCHN.

In the phase I part of this trial the dose of cilengitide in combination with cisplatin, 5-FU and cetuximab will be determined. The phase I part will be conducted in dedicated study centers. In the phase II part of this trial, cilengitide will be administered at two different doses to two experimental groups. The third group will only receive cisplatin, 5-FU and cetuximab.

Cilengitide is an experimental anti-cancer substance interacting with so-called integrins. Integrins are protein molecules that are known to be present on the surface of certain cancer cells. Integrins are also found on certain cells that belong to growing blood vessels (endothelial cells). Integrins potentially facilitate the blood vessels' support of the tumor (angiogenesis) as well as the tumor's growth and further spread throughout the body (metastasis). By inhibiting integrins on the tumor cell surface, cilengitide potentially kills cancer cells, and potentially sensitizes cancer cells to other co-administered therapeutics. By inhibiting integrins on the endothelial cell surface it potentially inhibits the ingrowth of additional blood vessels towards the tumor.

Cilengitide will be given as an intravenous infusion (given by a drip in one vein of your arm). If any unacceptable side effect occurs, treatment with the study drug will be stopped.