Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer

Status unconfirmed

Conditions studied: Colorectal Cancer, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT00133913

Run by

Immunicon

People needed

486

Starts

2004-03-01

Expected to finish

2009-01-01

Last updated by the study team

2008-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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