Cancer Stem Cell Markers and Prognostic Markers in Circulating Tumor Cells

NCT ID: NCT01286883

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-09-30

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.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Blood draws

Laboratory studies will be performed at baseline; Cycle 1, Day 1; Cycle 1, Day 7; Cycle 2, Day 1; Cycle 3, Day 1; Cycle 4, Day 1; Cycle 6, Day 1; Cycle 12, Day 1.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wafik S El-Deiry, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Locations

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20890370 (View on PubMed)

Other Identifiers

PSHMC IRB No. 34902EP

Identifier Type: OTHER

Identifier Source: secondary_id

PSHCI 10-066

Identifier Type: -

Identifier Source: org_study_id