Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Rome Tor Vergata
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Circulating Regulatory Lymphocytes and Outcome of Metastatic Colorectal Cancer Patients
