Clinical trial · Interventional
Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer
Randomized Phase 3 Study on the Optimization of Bevacizumab With mFOLFOX/mOXXEL in the Treatment of Patients With Metastatic Colorectal Cancer
NCT01718873CI-TRIAL-00065572OBELICScompletedPhase 3Results postedClinicalTrials.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)
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.
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 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| levo-folinic acid | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- bevacizumab before chemotherapy
- description
- Bevacizumab administered 4 days before each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
- interventionNames
- Drug: Bevacizumab
- Drug: Oxaliplatin
- Drug: levo-folinic acid
- Drug: 5-fluorouracil
- Drug: Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- bevacizumab with chemotherapy
- description
- Bevacizumab administered on the first day of each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
- interventionNames
- Drug: Bevacizumab
- Drug: Oxaliplatin
- Drug: levo-folinic acid
- Drug: 5-fluorouracil
- Drug: Capecitabine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 \< 2000 / mm3, platelets \< 100,000 / mm3, hemoglobin \< 9g/dl * Creatinine \> 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
References
Publications (2)
- DERIVEDAvallone A, Piccirillo MC, Nasti G, Rosati G, Carlomagno C, Di Gennaro E, Romano C, Tatangelo F, Granata V, Cassata A, Silvestro L, De Stefano A, Aloj L, Vicario V, Nappi A, Leone A, Bilancia D, Arenare L, Petrillo A, Lastoria S, Gallo C, Botti G, Delrio P, Izzo F, Perrone F, Budillon A. Effect of Bevacizumab in Combination With Standard Oxaliplatin-Based Regimens in Patients With Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2118475. doi: 10.1001/jamanetworkopen.2021.18475. PMID 34309665
- DERIVEDAvallone A, Piccirillo MC, Aloj L, Nasti G, Delrio P, Izzo F, Di Gennaro E, Tatangelo F, Granata V, Cavalcanti E, Maiolino P, Bianco F, Aprea P, De Bellis M, Pecori B, Rosati G, Carlomagno C, Bertolini A, Gallo C, Romano C, Leone A, Caraco C, de Lutio di Castelguidone E, Daniele G, Catalano O, Botti G, Petrillo A, Romano GM, Iaffaioli VR, Lastoria S, Perrone F, Budillon A. 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). BMC Cancer. 2016 Feb 8;16:69. doi: 10.1186/s12885-016-2102-y. PMID 26857924