Clinical trial · Interventional
First-line Irinotecan, Lederfolin and 5FU (FOLFIRI) and Bevacizumab in Patients With Advanced Colorectal Cancer
First-line FOLFIRI and Bevacizumab in Patients With Advanced Colorectal Cancer Prospectively Stratified According to Serum LDH
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Stage II | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab and FOLFIRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Bevacizumab and FOLFIRI
- description
- Bevacizumab 5 mg/kg d1 q14 in combination with FOLFIRI (Irinotecan, leucovorin, 5FU I.V.bolus and 5FU I.V. c.i.)
- interventionNames
- Drug: Bevacizumab and FOLFIRI
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- RR will be evaluated every 12 weeks for 24 months
- description
- Response rate to ascertain whether bevacizumab in combination with chemotherapy could determine an improved response rate in patients with high LDH serum levels compared to patients with normal LDH serum levels
Secondary outcomes (2)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available