Status:
COMPLETED
First-line Irinotecan, Lederfolin and 5FU (FOLFIRI) and Bevacizumab in Patients With Advanced Colorectal Cancer
Lead Sponsor:
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Collaborating Sponsors:
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Conditions:
Colorectal Cancer Stage II
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Bevacizumab in combination with chemotherapy represents a standard of care for first-line treatment in patients with advanced colorectal cancer. Molecular predictive factors for bevacizumab efficacy h...
Detailed Description
The VEGF-driven tumour pathway has been demonstrated to represent a novel therapeutic target for an innovative class of antineoplastic agents. Among these antiangiogenetic-targeted treatment modalitie...
Eligibility Criteria
Inclusion
- Written informed consent
- No prior treatment for advanced disease (adjuvant therapy allowed)
- age \< 75 years \< 18 years
- Histologically/cytologically confirmed advanced, colorectal cancer
- At least one lesion measurable with CT or MRI scan
- Performance Status (ECOG) 0-1 at study entry)
- Life expectancy of at least 6 months
- Neutrophils count =/\> 1.5 x 109/L, platelets count =/\> 100 x 109/L, HGB =/\> 10 g/dL
- total bilirubin \< 1.5 x UNL • SGOT and SGPT =/\< 2.5 x UNL (=/\< 5 x UNL in patients with liver metastases)
- Creatinine \< 1.5 x UNL
Exclusion
- CNS metastases
- Severe cardiovascular disease
- Uncontrolled infections
- Radiotherapy within 4 weeks of study entry
- Any experimental drug administered within 4 weeks of study entry
- Known hypersensitivity to study drug
- Known drugs or alcohol abuse
- Pregnant or lactating women (serum Betahcg test)
- Other tumours, except in situ melanoma or cervix cancer if radically removed
- Incapability to sign informed consent
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01853813
Start Date
May 1 2013
End Date
July 1 2015
Last Update
July 15 2015
Active Locations (13)
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1
A.O. Universitaria - Ospedali Riuniti
Ancona, Ancona, Italy, 60100
2
A.O. Ospedale G.Rummo
Benevento, Benevento, Italy, 82100
3
A.O. Treviglio-Caravaggio, P.le Ospedale n1
Treviglio, Bergamo, Italy, 24047
4
Istituto Ospedaliero Fondazione Poliambulanza
Brescia, Brescia, Italy, 25124