Circulating Regulatory Lymphocytes and Outcome of Metastatic Colorectal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01533740
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : February 4, 2014
Information provided by (Responsible Party):
Vincenzo Formica, University of Rome Tor Vergata

Brief Summary:
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

Condition or disease Intervention/treatment
Metastatic Colorectal Cancer Drug: fluorouracil/irinotecan/levo-folinic acid/bevacizumab

Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : March 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: fluorouracil/irinotecan/levo-folinic acid/bevacizumab
    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 Outcome Measures :
  1. Impact of Tregs frequency on overall survival [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Impact of Tregs frequency progression free survival [ Time Frame: 12 months ]
  2. Impact of Tregs frequency radiologic response rate [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
whole blood sample

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital setting, single-center study, metastatic colorectal cancer patients treated with standard first line chemotherapy

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01533740

'Tor Vergata' University Hospital
Rome, Lazio, Italy, 00133
Sponsors and Collaborators
University of Rome Tor Vergata
Principal Investigator: Vincenzo Formica, MD, PhD 'Tor Vergata' University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vincenzo Formica, MD, PhD, University of Rome Tor Vergata Identifier: NCT01533740     History of Changes
Other Study ID Numbers: ONCOPTV-01-2012
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Folic Acid
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action