Circulating Regulatory Lymphocytes and Outcome of Metastatic Colorectal Cancer Patients

Aim of the present study is to investigate whether baseline or early post-treatment (one month after treatment commencement) frequency of peripheral T regulatory lymphocytes (Tregs OR CD4+/CD25high/FOXP3+ T cells), known to suppress antitumor immune response, may influence long-term clinical outcome (i.e. radiological response, progression-free survival or overall survival) in metastatic colorectal cancer patients treated with a standard first-line chemotherapy including fluorouracil, irinotecan and bevacizumab

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

'Tor Vergata' University Hospital

Rome, Lazio, 00133, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with histologically or cytologically confirmed diagnosis of metastatic colorectal cancer not amenable to surgery
Adjuvant treatment ended ≥6 months before the study entry
No prior exposure to irinotecan and/or bevacizumab in the adjuvant treatment
No prior exposure to cytotoxic drugs for the metastatic disease
At least one measurable lesion according to the RECIST criteria
adequate laboratory parameters (Hemoglobin level ≥ 9.0 g/dL; Neutrophil count > 1.5 x 109/L; Platelets count >100 x 109/L; Total bilirubin <1.5 time the upper-normal limits (UNL) and ASAT (SGOT) and/or ALAT (SGPT) <2.5 x UNL, or <5 x UNL in case of liver metastases; alkaline phosphatase <2.5 x UNL, or <5 x UNL in case of liver metastases; PT-INR/PTT < 1.5 x UNL;Creatinine clearance > 50 mL/min or serum creatinine <1.5 x UNL; Urine dipstick of proteinuria < 2+)
Written informed consent.
Patients must be accessible for treatment and follow up.

Exclusion criteria

Untreated brain metastases or spinal cord compression
History of inflammatory bowel disease and/or acute or subacute bowel occlusion.
Serious, non-healing wound, ulcer, or bone fracture
Evidence of bleeding diathesis or coagulopathy.
Uncontrolled hypertension.
Clinically significant cardiovascular disease(cerebrovascular accidents ≤ 6 months, myocardial infarction ≤ 6 months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication)
Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes.
Chronic, daily treatment with high-dose aspirin (>325 mg/day) or other medications known to predispose to gastrointestinal ulceration.
Treatment with any investigational drug within 30 days prior to enrolment.
Patients with known allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications
Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.
Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline
Substance abuse, medical, psychological or social conditions that may interfere with the participation into the study or the evaluation of study results
Patients unable to swallow oral medications

Treatment and study plan

fluorouracil/irinotecan/levo-folinic acid/bevacizumab

Drug

standard first line chemotherapy with: bevacizumab 5 mg/kg intravenous (i.v.) infusion on day 1; irinotecan 180 mg/m2 i.v. infusion on day 1, levo-folinic acid 200 mg/m2 i.v. infusion on day 1, 5-fluorouracil 400 mg/m2 i.v. bolus on day 1 and 2,400 mg/m2 i.v. infusion over 46 hours; infusions repeated every 2 weeks

Other names: avastin (bevacizumab), campto (irinotecan)

Primary outcomes

Impact of Tregs frequency on overall survival

Time frame: 12 months

Secondary outcomes

Impact of Tregs frequency progression free survival

Time frame: 12 months
Impact of Tregs frequency radiologic response rate

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

Observational Study of the Impact of Circulating T Regulatory Cells (Tregs) on Clinical Outcome of Metastatic Colorectal Cancer (MCRC) Patients Treated With Standard Fluorouracil/Irinotecan/Bevacizumab First Line Therapy

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Feb 15, 2012
Registry last updated: Feb 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed