At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed colorectal adenocarcinoma with distant metastases
- ✓Documented disease progression during or within 6 months after most recent chemotherapy with fluoropyrimidine, irinotecan, and oxaliplatin
- ✓Tumor expresses EGFr by immunohistochemistry
- ✓2 to 3 prior chemotherapy regimens for colorectal cancer
- ✕Symptomatic brain metastases requiring treatment
- ✕History or evidence of interstitial pneumonitis or pulmonary fibrosis
- ✕Prior EGFr-targeting therapies
- ✕Chemotherapy or radiotherapy within 30 days prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer
In Brief
A Phase 3 clinical trial evaluating Best supportive care and Panitumumab for Colorectal Cancer and Metastases. Completed, enrolled 463 participants.
Detailed Summary
The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).
Study Details
Timeline
Interventions
Best supportive care as site routine excluding: antineoplastic chemotherapy, investigational agents, anti-EGFr(Epidermal growth factor receptor) targeting agents other than ABX-EGF(Panitumumab), experimental or approved anti-tumor therapies (e.g. Avastin), chemotherapy, radiotherapy (with the exception of radiotherapy for pain control limited to bone metastases).
Intravenous infusion at a dose of 6 mg/kg once every 2 weeks.