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Cancer Stem Cell Markers and Prognostic Markers in Circulating Tumor Cells

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Milton S. Hershey Medical Center
Sponsor:
Information provided by (Responsible Party):
Wafik El-Deiry, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01286883
First received: January 28, 2011
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Stem Cell and Prognostic Markers in Circulating Tumor Cells of Patients With Metastatic Colorectal Cancer Undergoing Chemotherapy

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Primary endpoint: correlation of stem cell markers on CTCs with response to therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Correlate the presence of stem cell markers and prognostic markers on circulating tumor cells with response to therapy for advanced colorectal cancer, as well as overall survival


Secondary Outcome Measures:
  • Secondary Outcome: Correlation of stem cell markers in primary tumors with stem cell markers in CTCs [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Evaluate the primary tumor if available for stem cell markers and prognostic markers. Perform genomic analysis of CTC DNA. Compare genomic analysis of primary tumor and CTC DNA. Evaluate CTC gene expression profiles and compare with primary tumor profiles. Evaluate emerging microfluidic devices in pilot studies that use drops of blood for CTC analysis.


Biospecimen Retention:   Samples With DNA

Blood will be drawn at 7 different time intervals to analyze CSC and other prognostic markers on circulating tumor cells.


Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with metastatic colorectal cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286883

Contacts
Contact: Wafik S El-Deiry, MD, PhD 717-531-5059 wafik.eldeiry@gmail.com
Contact: David Dicker 717-531-5101 dtd2@psu.edu

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Wafik S. El-Deiry, MD, PhD    717-531-5059    weldeiry@hmc.psu.com   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Wafik S El-Deiry, MD, PhD Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
  More Information

Publications:
Responsible Party: Wafik El-Deiry, Professor of Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01286883     History of Changes
Other Study ID Numbers: PSHCI 10-066, PSHMC IRB No. 34902EP
Study First Received: January 28, 2011
Last Updated: January 3, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Milton S. Hershey Medical Center:
stem cell markers
prognostic markers
metastatic colorectal cancer
circulating tumor cells
tumor microenvironment
colorectal cancer
advanced colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplastic Cells, Circulating
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases

ClinicalTrials.gov processed this record on November 27, 2014