Clinical trial · Interventional
Safety and Efficacy of Folfox4 + Weekly Cetuximab vs Folfox 4+Biweekly Cetuximab by Metastatic Colorectal Cancer
A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX4 + Weekly Cetuximab Versus FOLFOX4+ Biweekly Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer.
NCT00479752CI-TRIAL-00020980CORE 2completedPhase 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)
To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOX4 (Oxaliplatin), Cetuximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- FOLFOX4: * Oxaliplatin 85 mg/m² d1 * Leucovorin 200 mg/m² d1+d2, followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 600 mg/m²,over 22 hours, every 2 weeks Cetuximab is administered to arm A of the study as an infusion with initial dose 400 mg/m² in week 1 followed by weekly doses of 250 mg/m².
- interventionNames
- Drug: FOLFOX4 (Oxaliplatin), Cetuximab
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- FOLFOX4: * Oxaliplatin 85 mg/m² d1 * Leucovorin 200 mg/m² d1+d2, followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 600 mg/m², over 22 hours, every 2 weeks Cetuximab is administered to arm B of the study as infusions of 500 mg/m² every two weeks.
- interventionNames
- Drug: FOLFOX4 (Oxaliplatin), Cetuximab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent * Male or female ≥ 18 years of age * Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * Metastatic colorectal carcinoma not suitable for curative-intent resection- Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment * Presence of at least one lesion measurable unidimensionally by CT scan or MRI. (Target lesion(s) must not lie within an irradiated area) * Karnofsky performance status of \> 80 at study entry * Leucocytes ≥ 3.0 x 10 9/L and neutrophils ≥1.5 x 10 9/L, platelets ≥ 100 x 10 9/L, and hemoglobin ≥ 9 g/dL. * Bilirubin ≥ 1.5 x ULN * ASAT and ALAT ≤ 2.5 x ULN (≤5 x ULN if liver metastasis are present) * Serum creatinine ≤ 1.5 x ULN Exclusion Criteria: * Brain metastasis (known or suspected) * Previous chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed if the chemotherapy treatment free interval is \> 6 months. * Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry * Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol * Any investigational agent(s) within 4 weeks prior to entry * Previous exposure to EGFR-pathway targeting therapy * Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months * Acute or subacute intestinal occlusion or history of inflammatory bowel disease * Pre-existing neuropathy \> grade 1. In case of prior oxaliplatin containing adjuvant chemotherapy: pre-existing neuropathy ≥ 1. * Known grade 3 or 4 allergic reaction to any of the components of the treatment. * Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial) * Pregnancy or lactation * Inadequate contraception (male or female patients) if of childbearing or procreational potential * Known drug abuse/ alcohol abuse * Legal incapacity or limited legal capacity * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.