METASTATIC COLORECTAL CANCER PATIENTS MedDRA version: 9.1 Level: LLT Classification code 10052358 Term: Colorectal cancer metastatic
Conditions
Interventions
Trade Name: AVASTIN
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Bevacizumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: #61485; Histologically confirmed colorectal adenocarcinoma; #61485; Unresectable and measurable metastatic disease according to RECIST criteria (40); #61485; Progressive disease after or during first-line chemotherapy for metastatic disease including a fluoropyrimidine-based monotherapy + Bevacizumab or a fluoropyrimidine and irinotecan based doublet + Bevacizumab or a fluoropyrimidine and oxaliplatin based doublet + Bevacizumab. #61485; Progressive disease after more than 3 months of first-line chemotherapy for metastatic disease with a fluoropyrimidine, irinotecan and oxaliplatin triplet (FOLFOXIRI) + Bevacizumab to which the patient had previously responded #61485; Male or female, aged > 18 years and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:  First-line chemotherapy for metastatic disease without bevacizumab;  Prior treatment with Cetuximab or other investigational agents;  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) (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ 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: To compare the progression-free-survival of second-line chemotherapy with Bevacizumab to second-line chemotherapy alone in patients treated with first-line chemotherapy + Bevacizumab.;Secondary Objective: To compare the progression-free-survival of second-line chemotherapy with Bevacizumab to second-line chemotherapy alone in patients treated with first-line chemotherapy + Bevacizumab.;Primary end point(s): progression-free-survival | — |
Countries
Italy
Outcome results
None listed