Clinical trial · Interventional
Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment
Phase II Study of Bevacizumab-containing Regimen in Patients With Metastatic Colorectal Cancer Who Failed to Cytotoxic Treatment
NCT02226289CI-TRIAL-00046916BATTLEunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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, a humanized monoclonal antibody against vascular endothelial growth factor (VEGF), combined with fluoropyrimidine-based chemotherapy is now the standard first and second-line treatment for metastatic colorectal cancer. The efficacy of bevacizumab with cytotoxic agents in the third-line treatment of patients with mCRC is still unknown.
Conditions
Conditions (3)
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 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Neoplasm | Neoplasm | CURATED_BROADER | 0.78 |
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bevacizumab-containing
- description
- bevacizumab with the latest received cytotoxic regimen
- interventionNames
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Baseline and 6 weeks
- description
- Percentage of tumor regression
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- From date of treatment until the date of death of any cause, assessed up to 48 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent obtained. * Subjects must be able to understand and willing to sign a written informed consent. * Subjects \> 18 years of age * Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2. * Histological or cytological diagnosis of adenocarcinoma of the colon or rectum. * Subjects have unresectable metastatic lesions. * Subjects failed to respond to oxaliplatin, irinotecan and fluorouracil. * Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria measured within 4 weeks prior to registration. * Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥ 9g/ dL. * Total bilirubin ≤1.5 x the upper limit of normal (ULN). * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN. * Amylase and lipase ≤ 1.5 x the ULN. * Serum creatinine ≤ 1.5 x the ULN. * Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min. Exclusion Criteria: * Any previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to this study. * Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization. * Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks before start of study medication. * Uncontrolled hypertension. (systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management). * Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication. * Any evidence of active infection. * Known history of human immunodeficiency virus (HIV) infection. * History of bleeding diathesis or coagulopathy. * History of interstitial pneumonitis or pulmonary fibrosis * Pregnancy or lactation at the time of study entry. * Any history of or currently known brain metastases. * Known dihydropyrimidine dehydrogenase (DPD) deficiency * Any illness or medical conditions that are unstable or could jeopardize the safety of the subjects and his/her compliance in the study. * Subjects with known allergy to the study drugs or to any of its excipients. * Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
References
Publications (0)
Data not yet available
No reference posted for this study.