Clinical trial · Interventional
Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer
A Randomized Phase II Study of Modified FOLFOX6 (Infusional 5-Fluorouracil/Leucovorin, Oxaliplatin) and Bevacizumab With or Without Cetuximab in Patients With Metastatic Colorectal Cancer
NCT00193219CI-TRIAL-00055868completedPhase 2Results 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)
This trial will evaluate the combination of modified infusional 5-fluorouracil/ leucovorin, oxaliplatin (FOLFOX6), bevacizumab, and cetuximab in patients with metastatic colorectal cancer. FOLFOX6 has proven to be a safe and effective regimen in first line treatment of advanced colorectal cancer. The role of epidermal growth factor (EGFR) inhibitors in an earlier treatment setting in combination with optimal chemotherapy regimens is an important emerging question.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
- interventionNames
- Drug: Bevacizumab
- Drug: Cetuximab
- Drug: 5-fluorouracil
- Drug: Leucovorin
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
- timeFrame
- 18 months
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: To be included in the study, you must meet the following criteria: * Metastatic colorectal cancer confirmed by a biopsy sample * 18 years of age or older * Evidence of disease progression at time of study entry * At least one prior adjuvant chemotherapy regimen * No prior therapy for metastatic disease * Measurable disease * Able to perform activities of daily living with minimal assistance * Adequate bone marrow, kidney, and liver function * Tumor tissue available for assessment of EGFR * Signed informed consent Exclusion Criteria: You cannot participate in the study if any of the following apply to you: * Treatment with a previous regimen for metastatic disease * Prior treatment with any EGFR inhibitor or anti-angiogenic agents * Brain or nervous system metastases * History of severe thromboembolic event * Clinical evidence or history of bleeding or coagulopathy * History of stroke or heart attack within six months * Poorly controlled hypertension * Non-healing wound, ulcer, or bone fracture * History of abdominal fistula, perforation, or abscess within six months * Other uncontrolled or significant disease or medical condition Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
References
Publications (1)
- BACKGROUNDSpigel DR, Greco FA, Waterhouse D, Shipley D, Lane CM, Vazquez ER, Clark BL, Infante JR, Bendell JC, Burris HA 3rd, Hainsworth JD. Phase II trial of FOLFOX6, bevacizumab, and cetuximab in the first-line treatment of metastatic colorectal cancer. Clin Adv Hematol Oncol. 2010 Jul;8(7):480-5, 498. PMID 20864916