Clinical trial NCT01286883: Cancer Stem Cell Markers and Prognostic Markers in Circulating Tumor Cells
Official title: Prevalence of Stem Cell and Prognostic Markers in Circulating Tumor Cells of Patients With Metastatic Colorectal Cancer Undergoing Chemotherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colorectal Cancer
Keywords: stem cell markers
prognostic markers
metastatic colorectal cancer
circulating tumor cells
tumor microenvironment
colorectal cancer
advanced colorectal cancer
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2011-01-31
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic colorectal cancer

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary endpoint: correlation of stem cell markers on CTCs with response to therapy
timeFrame: 3 years
Secondary outcomes:
measure: Secondary Outcome: Correlation of stem cell markers in primary tumors with stem cell markers in CTCs
timeFrame: 3 years
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
name: Wafik S El-Deiry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen JE, El-Deiry WS. Circulating Tumor Cells and Colorectal Cancer. Curr Colorectal Cancer Rep. 2010 Oct 1;6(4):212-220. doi: 10.1007/s11888-010-0069-7.