First-line Irinotecan, Lederfolin and 5FU (FOLFIRI) and Bevacizumab in Patients With Advanced Colorectal Cancer

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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 have not yet been identified therefore selection of patients more likely to benefit from such a treatment approach is not possible. Retrospective analyses suggested that LDH serum levels may influence the clinical activity of anti-angiogenetic drugs. Primary aim of our clinical trial will be to prospectively ascertain whether bevacizumab in combination with chemotherapy has an improved clinical activity in patients with high LDH serum levels compared to patients with normal LDH serum levels

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
• Collaborator: Azienda Ospedaliero, Universitaria Ospedali Riuniti
• Treatments: Bevacizumab; Irinotecan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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