At a glance
ClinicalIndex Comparison Record- ✓Histologically or pathologically confirmed metastatic colorectal carcinoma
- ✓Documented disease progression after at least one standard chemotherapy regimen for metastatic disease
- ✓Prior chemotherapy regimen must have included a fluoropyrimidine
- ✓EGFR-negative disease confirmed by immunohistochemistry (biopsy required if tissue unavailable)
- ✕Prior cetuximab or other EGF pathway-targeted therapy
- ✕Prior hypersensitivity reaction to chimerized or murine monoclonal antibody
- ✕Symptomatic or uncontrolled CNS metastases, or those requiring glucocorticoids
- ✕Uncontrolled angina, arrhythmias, or congestive heart failure
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Multicenter Study of Erbitux (Cetuximab) in Patients With Refractory, EGFR-Negative Metastatic Colorectal Carcinoma
In Brief
A Phase 2 clinical trial evaluating cetuximab for Colorectal Neoplasms and 2 related conditions. Completed, enrolled 87 participants across 27 sites in 2 countries.
Detailed Summary
This is a phase II, multicenter, open-label study of cetuximab in patients with epidermal growth factor receptor (EGFR) negative, metastatic colorectal carcinoma who have progressed after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine. Target enrollment is 80 evaluable patients. Patients with EGFR-negative metastatic colorectal carcinoma who have progressed after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine, will receive an initial dose of cetuximab, 400 mg/m2 , intravenously (i.v.) over 120 minutes, followed by weekly treatment with cetuximab, 250 mg/m2 i.v. over 60 minutes. Patients who experience unacceptable toxicity or who have progressive disease (PD) will not receive further cetuximab therapy. Patients will be evaluated for a tumor response at a minimum of every 6 weeks while on cetuximab therapy. Patients with stable disease (SD), partial response (PR), or a complete response (CR) may continue to receive weekly cetuximab therapy, unless they are dose-delayed or discontinued because of toxicity. Patients who have a PR or CR must have a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response. To evaluate the objective response rate, a single-stage design will be used in this study.
Study Details
Timeline
Interventions
Initial dose of 400 mg/m2 intravenously (i.v.) over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes