Phase 3
Completed N=230
Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer
Colorectal Cancer
Source: ClinicalTrials.gov NCT01718873 ↗
Enrolled (actual)
230
Serious AEs
60.9%
Results posted
Apr 2023
Primary outcomePrimary: Objective Response Rate — 65; 66 participants
◆ Published Evidence
Established
34citations · ~7 / year
Effect of Bevacizumab in Combination With Standard Oxaliplatin-Based Regimens in Patients With Metastatic Colorectal Cancer: A Randomized Clinical Trial.
Summary
The purpose of this study is to evaluate if giving bevacizumab prior to chemotherapy compared to giving bevacizumab at the same time as chemotherapy improves patient overall response to treatment.
Linked Publications (2)
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Effect of Bevacizumab in Combination With Standard Oxaliplatin-Based Regimens in Patients With Metastatic Colorectal Cancer: A Randomized Clinical Trial.
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A randomized phase 3 study on the optimization of the combination of bevacizumab with FOLFOX/OXXEL in the treatment of patients with metastatic colorectal cancer-OBELICS (Optimization of BEvacizumab scheduLIng within Chemotherapy Scheme).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate |
65; 66 | — |
| SECONDARY Disease Control Rate |
107; 103 | — |
| SECONDARY Overall Survival |
29.8; 24.1 | — |
| SECONDARY Progression-free Survival (PFS) |
11.7; 10.5 | — |
| SECONDARY Toxic Effects |
108; 113 | — |
Eligibility Criteria
Inclusion Criteria
- Histological diagnosis of colorectal adenoma carcinoma
- Stage IV disease
- Presence of at least one measurable target lesion (according to RECIST), and not previously radiated.
- Age ≥ 18 e ≤ 75 years
- ECOG Performance status 0-1
- Life expectancy >3 months
- Adequate recovery from surgery, with at least 28 days from surgery to date of pre-study biopsy.
- Adequate contraception for male and female patients of child bearing potential
- informed consent
Exclusion Criteria
- More than one previous line of therapy for metastatic disease
- Prior treatment with bevacizumab or oxaliplatin (previous treatment with irinotecan,, cetuximab, fluoropyrimidine, folic acid are permitted)
- Primary tumor that is stenosing and/or that infiltrates the entire thickness of the intestinal wall
- Regular use of NSAIDs or aspirin
- Bleeding disorders or coagulopathy
- Concurrent anticoagulant therapy
- Suspected or cerebral metastases (to verify in the presence of symptoms)
- Neutrophils 1.5 times the upper normal limit
- GOT and/or GPT > 2.5 times the upper normal limit, bilirubin > 1.5 times the upper normal limit in absence of liver metastases
- GOT and/or GPT > 5 times the upper normal limit, bilirubin > 3 times the upper normal limit in presence of liver metastases
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ
- Congestive heart failure, ischemic coronary events within past 12 months, uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Active or uncontrolled infection
- Any concomitant condition that, in the investigator's opinion, would contraindicate the use of any of the study drugs
- Pregnancy or lactation
- Central nervous system disorders or peripheral neuropathy > grade 1 (CTCAE v. 4.0)
- Inability to comply with follow up procedures of the study
Data sourced from ClinicalTrials.gov (NCT01718873) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.