Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

— IMMC-06  

Official title:

Longitudinal Enumeration of Circulating Tumor Cells in Patients With Metastatic Colorectal Carcinomas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00133913
• Other study ID #: IMMC-06
• Status: Active, not recruiting
• Phase: N/A
• First received: August 22, 2005
• Last updated: March 17, 2008
• Start date: March 2004
• Est. completion date: January 2009

Study information

• Verified date: March 2008
• Source: Immunicon
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 486
• Est. completion date: January 2009
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm Metastasis
• Neoplastic Cells, Circulating

Intervention

Procedure:
• Phlebotomy
Peripheral blood draws for testing of circulating tumor cells

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Immunicon

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cohen SJ, Alpaugh RK, Gross S, O'Hara SM, Smirnov DA, Terstappen LW, Allard WJ, Bilbee M, Cheng JD, Hoffman JP, Lewis NL, Pellegrino A, Rogatko A, Sigurdson E, Wang H, Watson JC, Weiner LM, Meropol NJ. Isolation and characterization of circulating tumor cells in patients with metastatic colorectal cancer. Clin Colorectal Cancer. 2006 Jul;6(2):125-32. — View Citation

External Links

•   510(k) Premarket Notification