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Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer (IMMC-06)
This study is ongoing, but not recruiting participants.
Sponsored by: Immunicon
Information provided by: Immunicon
ClinicalTrials.gov Identifier: NCT00133913
  Purpose

This study enrolled patients with measurable metastatic colorectal cancer. Blood was drawn prior to the patient receiving a new therapy for his/her cancer and subsequently at 7-14 days, 3-4 weeks, and when an imaging study was done (~every 6 to 12 weeks). The blood was tested to find circulating tumor cells (CTCs) and to count them. The CTC levels were compared to the imaging study results to see if the CTC number and the imaging result (progression/no progression) were in agreement. Maximum active study participation was 12 months with up to 8 blood draws being taken. All patients are currently being followed for up to 24 months from their off study date for survival. The CTC result will also be used to see if there is a difference in survival and progression-free survival for those patients with and without a certain number of CTCs.


Condition Intervention
Colorectal Cancer
Neoplasm Metastasis
Procedure: Phlebotomy

MedlinePlus related topics: Cancer Colorectal Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Longitudinal Enumeration of Circulating Tumor Cells in Patients With Metastatic Colorectal Carcinomas

Further study details as provided by Immunicon:

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 486
Study Start Date: March 2004
Estimated Study Completion Date: January 2009
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort
Patients with measurable metastatic colorectal cancer about to start a new line of chemotherapy.
Procedure: Phlebotomy
Peripheral blood draws for testing of circulating tumor cells

  Eligibility

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

Oncology patients from academic institutions and private practices

Criteria

Inclusion Criteria:

  • Measurable metastatic carcinoma of the colon or rectum.
  • 1st or 2nd line chemotherapy (3rd line acceptable with epidermal growth factor receptor [EGFR] targeted therapy)
  • Chest/abdomen/pelvis scans every 6-12 weeks
  • ECOG 0-2
  • Hemoglobin (Hgb) > or = 8g/dl within 7 days prior to enrollment
  • Age > or = to 18 years of age

Exclusion Criteria:

  • Cumulative weekly blood draws exceeding 150mL/week
  • Brain metastasis
  • Prior history of other carcinoma within the last 5 years, except ductal carcinoma in situ (DCIS), non-invasive cervical cancer or non-melanoma skin cancer
  • Surgery within 14 days of the initial blood draw, excluding surgical placement of a central venous device
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133913

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Immunicon
Investigators
Principal Investigator: Steven Cohen, MD Fox Chase Cancer Center
  More Information

510(k) Premarket Notification  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Immunicon ( Senior Director, Clinical Development )
Study ID Numbers: IMMC-06
Study First Received: August 22, 2005
Last Updated: March 17, 2008
ClinicalTrials.gov Identifier: NCT00133913  
Health Authority: United States: Institutional Review Board

Keywords provided by Immunicon:
metastatic colorectal cancer

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms
Carcinoma

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009