Circulating Regulatory Lymphocytes and Outcome of Metastatic Colorectal Cancer Patients
This study is currently recruiting participants.
Verified February 2013 by University of Rome Tor Vergata
Information provided by (Responsible Party):
Vincenzo Formica, University of Rome Tor Vergata
First received: February 10, 2012
Last updated: February 3, 2013
Last verified: February 2013
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
Metastatic Colorectal Cancer
Drug: fluorouracil/irinotecan/levo-folinic acid/bevacizumab
||Observational Model: Cohort
Time Perspective: Prospective
||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
Primary Outcome Measures:
- Impact of Tregs frequency on overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2013 (Final data collection date for primary outcome measure)
metastatic colorectal cancer patients
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
- avastin (bevacizumab)
- campto (irinotecan)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Hospital setting, single-center study, metastatic colorectal cancer patients treated with standard first line chemotherapy
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533740
|'Tor Vergata' University Hospital
|Rome, Lazio, Italy, 00133 |
|Contact: Vincenzo Formica, MD,PhD +390620908190 firstname.lastname@example.org |
|Principal Investigator: Vincenzo Formica, MD, PhD |
University of Rome Tor Vergata
||Vincenzo Formica, MD, PhD
||'Tor Vergata' University Hospital
No publications provided
||Vincenzo Formica, MD, PhD, University of Rome Tor Vergata
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 10, 2012
||February 3, 2013
||Italy: Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vitamin B Complex