Clinical trial · Interventional
A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab
- 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 randomized, open-label study will evaluate the safety and efficacy of Avastin (Bevacizumab) added to standard mFOLFOX6 chemotherapy in treatment-naïve patients with Stage IV metastatic colorectal cancer. According to K-RAS gene mutation status, patients will be assigned or randomized to receive either Avastin 5 mg/kg intravenously (iv) on Day 1 of each 2-week cycle or cetuximab 400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week, in addition to mFOLFOX6 every 2 weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab [Avastin] | Drug | Bevacizumab | ALIAS |
| cetuximab | Drug | Cetuximab | ALIAS |
| mFOLFOX6 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- K-RAS mutated
- interventionNames
- Drug: bevacizumab [Avastin]
- Drug: mFOLFOX6
- type
- EXPERIMENTAL
- label
- K-RAS native A
- interventionNames
- Drug: bevacizumab [Avastin]
- Drug: mFOLFOX6
- type
- ACTIVE_COMPARATOR
- label
- K-RAS native B
- interventionNames
- Drug: cetuximab
- Drug: mFOLFOX6
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients \>/= 18 years of age * Histologically confirmed adenocarcinoma of the colon or rectum * Stage IV metastatic disease with at least one measurable metastatic lesion according to RECIST criteria * Tumour tissue sample available for assessment of K-RAS and BRAF genes * Prior radiotherapy must have been completed 4 weeks before randomization * Adequate bone marrow, kidney and liver function * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Exclusion Criteria: * Previous chemotherapy for metastatic disease * Completion of adjuvant treatment for colorectal cancer (Stage I, II and III) in the 12 months preceding randomization * Prior treatment with bevacizumab, cetuximab or other EGFR inhibitors * Clinical or radiographic evidence of brain metastases * Clinically significant cardiovascular disease or disorder * History of neoplastic disease other than colorectal cancer in the 3 years prior to start of study treatment, except for successfully treated non-invasive carcinomas such as cervical cancer in situ, basal cell carcinoma of the skin or superficial bladder tumours * HIV, hepatitis B or C infection
References
Publications (0)
Data not yet available