IN PATIENTS WITH METASTATIC COLORECTAL CANCER. MedDRA version: 9.1 Level: HLT Classification code 10009945 Term: Colonic neoplasms malignant
Conditions
Interventions
Trade Name: AVASTIN*INFUS 1FL 400MG
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: BEVACIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4
Sponsors
G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:  Histologically confirmed colorectal adenocarcinoma;  Unresectable and measurable metastatic disease (RECIST criteria);  Male or female, aged > 18 years and = 1.5 x 109/L; platelets >= 100 x 109/L, Hb >= 9 g/dL;  INR = 2+, 24- hour urine must demonstrate =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:  Prior palliative chemotherapy;  Prior treatment with bevacizumab;  Bowel obstruction (or subobstruction). History of inflammatory enteropathy or extensive intestinal resection (> hemicolectomy or extensive small intestine resection with chronic diarrhea);  Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria;  Presence or history of CNS metastasis;  Active uncontrolled infections; active disseminated intravascular coagulation;  Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study. Central Venous Access Device (CVAD) for chemotherapy administration inserted within 2 days prior to study treatment start;  Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix;  Clinically significant cardiovascular disease, for example cerebrovascular accidents (CVA) (= grade 2 chronic heart failure (CHF), uncontrolled arrhythmia;  Uncontrolled hypertension;  24-hour urine protein > 1 g if dipstick > 2+;  History of thromboembolic or hemorrhagic events within 6 months prior to treatment;  Evidence of bleeding diathesis or coagulopathy;  Serious, non healing wound/ulcer or serious bone fracture;  No therapeutic anticoagulation or antiplatelet agents or NSAID with anti-platelet activity (aspirin <= 325 mg/day allowed);  Pregnancy or lactation;  Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression free survival.;Secondary Objective: - Response rate. - Overall survival. - Safety profile. - Evaluation of potential surrogate markers predictive of bevacizumab activity.;Primary end point(s): Progression free survival. | — |
Countries
Italy
Outcome results
None listed