Cancer Stem Cell Markers and Prognostic Markers in Circulating Tumor Cells
Cancer Stem Cell Markers and Prognostic Markers in Circulating Tumor Cells
The study will enroll patients with metastatic colorectal cancer receiving chemotherapy. A
 total of approximately 22 cc of blood will be drawn during various chemotherapy infusions.
 Additional proposed laboratory studies may unravel important biological insights into the
 relationship of circulating tumor cell genomic and genetic profiles as they compare to the
 primary tumors. Additionally the investigators hope to gain an understanding of potential
 subgroups of patients that have very high numbers of circulating tumor cells or those with
 early relapse of circulating tumor cells after early reduction of circulating tumor cell
 numbers.
Metastatic colorectal cancer (mCRC) has a five year survival of <10% and is the cause of
 death of nearly 50,000 individuals in the United States each year. Current first and second
 line therapies for mCRC include FOLFOX, XELOX, or FOLFIRI in combination with Bevacizumab or
 Cetuximab or Panitumumab, as well as Xeloda, camptosar or infusional 5-FU within various less
 intensive regimens for patients who cannot tolerate full-dose chemotherapy. Current practice
 involves evaluation of response by imaging at 2-3 months after initiation of therapy. Recent
 studies have demonstrated that the number of circulating tumor cells (CTCs) in the blood of
 patients with mCRC has independent prognostic value in terms of reflecting disease burden as
 well as indicating response to therapy. The use of CTC counts offers the possibility of
 predicting response in treated patients at an earlier time than through standard means by
 using CT scans. The investigators hypothesize that subsets of CTCs with cancer stem cell
 (CSC) markers or other known prognostic markers may improve the prognostic value of CTC
 evaluation in the course of therapy of patients with mCRC. The protocol will use Veridex
 CellSearch technology and will when possible compare this to other emerging technologies
 including microfluidic devices that can isolate CTCs or GFP-expressing adenoviruses that
 replicate in telomerase-expressing epithelial tumor cells ex-vivo. The protocol will enroll
 200 patients with metastatic colorectal cancer receiving therapy. Additional proposed
 laboratory studies may unravel important biological insights into the relationship of CTC
 genomic and genetic profiles as they compare to the primary tumors. Additionally the
 investigators hope to gain an understanding of potential subgroups of patients that have very
 high numbers of CTCs or those with early relapse of CTC after early reduction of CTC numbers.
 The impact of this research may be in better prediction of response to mCRC therapy so that
 patients can be treated with second line or other experimental therapy if they are unlikely
 to respond to their current therapy as predicted by CTC evaluation.
Inclusion Criteria:

 -  Patients with the diagnosis of metastatic colorectal cancer, either newly diagnosed or
 recurrent, with measurable disease that has not been irradiated within the last 5
 weeks.

 -  Age > 18 years old

 -  ECOG performance status 0-3

 Exclusion Criteria:

 -  Patients who have received prior therapy in the last 5 weeks

 -  Ongoing therapy with a particular regimen that was initiated prior to enrollment and
 lack of availability of baseline CTC evaluation

 -  Patient with concurrent diagnosis of other active solid malignancies will be exclude

 -  Patient life expectancy of less than six weeks