Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory/Ineligible, Advanced, Squamous Cell Carcinoma
Status:
Terminated
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
The primary hypothesis of this study is that the addition of mammalian target of rapamycin
(mTOR) blockade to conventional epidermal growth factor receptor (EGFR) blockade will result
in synergistic clinical activity in Squamous Cell Carcinoma of the Head and Neck (SCCHN),
consistent with preclinical xenograft data. Patients will be treated with the combination of
temsirolimus and erlotinib, at the previously established Maximal Tolerated Dose (MTD). The
primary signal of efficacy will be progression free survival (PFS), anticipating that PFS
will be prolonged compared to historical PFS in SCCHN patients treated with erlotinib or
cetuximab monotherapy.