NCT01533740

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

1.9 years

First QC Date

February 10, 2012

Last Update Submit

February 1, 2014

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Impact of Tregs frequency on overall survival

    12 months

Secondary Outcomes (2)

  • Impact of Tregs frequency progression free survival

    12 months

  • Impact of Tregs frequency radiologic response rate

    6 months

Interventions

fluorouracil/irinotecan/levo-folinic acid/bevacizumabDRUG

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

Also known as: avastin (bevacizumab), campto (irinotecan)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital setting, single-center study, metastatic colorectal cancer patients treated with standard first line chemotherapy

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

'Tor Vergata' University Hospital

Rome, Lazio, 00133, Italy

Location

Related Publications (1)

  • Formica V, Cereda V, di Bari MG, Grenga I, Tesauro M, Raffaele P, Ferroni P, Guadagni F, Roselli M. Peripheral CD45RO, PD-1, and TLR4 expression in metastatic colorectal cancer patients treated with bevacizumab, fluorouracil, and irinotecan (FOLFIRI-B). Med Oncol. 2013 Dec;30(4):743. doi: 10.1007/s12032-013-0743-0. Epub 2013 Oct 11.

    PMID: 24114613DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood sample

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

FluorouracilBevacizumabIrinotecan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCamptothecinAlkaloids

Study Officials

  • Vincenzo Formica, MD, PhD

    'Tor Vergata' University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 15, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

IT(1)