This is an investigator initiated phase II study to assess the efficacy of a chemotherapy
called nab-paclitaxel as first line cytotoxic chemotherapy in subjects with unresectable
locally advanced or metastatic cutaneous squamous cell carcinoma (SCC). All subjects receive
the treatment by vein weekly and receive the same dose of the treatment.
The risk of developing cutaneous SCC is approximately 10% in a lifetime. The vast majority
are treated surgically and do not recur. However a small percentage become unresectable over
time or metastasize distantly in the body. Unresectable and metastatic cutaneous SCC has a
poor prognosis and oncologists often choose a whole body therapy without the benefit of
prospective efficacy data. Very little prospective investigation into the efficacy of
specific chemotherapy regimens as a function of line of therapy has been performed in this
patient population. Nab-paclitaxel is type of chemotherapy that has demonstrated activity in
other types of cancer such as lung and head and neck cancers. The primary objective of this
study is to determine the response rate (percentage of subjects with tumor shrinkage) to
nab-paclitaxel treatment in subjects with cutaneous SCC who have not received cytotoxic
chemotherapy in the unresectable or the metastatic settings.. Secondary objectives are the
progression free survival (time until tumor starts to grow), safety, assessment of the
percentage of subjects whose tumor expresses a protein called SPARC, and correlating the
expression of SPARC with response to treatment. To determine if the tumor expresses SPARC
part of a prior standard biopsy such as that performed to establish the diagnosis of SCC will
be used. SPARC is a protein that is overexpressed in a range of different cancer types and
may alter the environment around the tumor possibly in a way that may make the SCC more
responsive to treatment with nab-paclitaxel.