Clinical trial NCT00133913: Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer
Official title: Longitudinal Enumeration of Circulating Tumor Cells in Patients With Metastatic Colorectal Carcinomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Neoplasm Metastasis
Keywords: metastatic colorectal cancer
Lead sponsor: Immunicon
Sponsor class: INDUSTRY
First posted: 2005-08-24
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Oncology patients from academic institutions and private practices

Brief 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Steven Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.3816/CCC.2006.n.029.
citation: Coumans FA, Ligthart ST, Uhr JW, Terstappen LW. Challenges in the enumeration and phenotyping of CTC. Clin Cancer Res. 2012 Oct 15;18(20):5711-8. doi: 10.1158/1078-0432.CCR-12-1585. Epub 2012 Sep 25.