Circulating Regulatory Lymphocytes and Outcome of Metastatic Colorectal Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vincenzo Formica, University of Rome Tor Vergata
ClinicalTrials.gov Identifier:
NCT01533740
First received: February 10, 2012
Last updated: February 1, 2014
Last verified: February 2014
  Purpose

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 Intervention
Metastatic Colorectal Cancer
Drug: fluorouracil/irinotecan/levo-folinic acid/bevacizumab

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Rome Tor Vergata:

Primary Outcome Measures:
  • Impact of Tregs frequency on overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of Tregs frequency progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Impact of Tregs frequency radiologic response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood sample


Enrollment: 31
Study Start Date: March 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
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)
  Eligibility

Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533740

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

No publications provided

Responsible Party: Vincenzo Formica, MD, PhD, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT01533740     History of Changes
Other Study ID Numbers: ONCOPTV-01-2012
Study First Received: February 10, 2012
Last Updated: February 1, 2014
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Irinotecan
Fluorouracil
Folic Acid
Levoleucovorin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014