At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Induction Cetuximab (IM-C225), Gemcitabine and Oxaliplatin, Followed by Radiotherapy With Concurrent Capecitabine, and Cetuximab, Followed by Maintenance Cetuximab and Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
In Brief
A Phase 2 clinical trial evaluating Cetuximab, Gemcitabine, and 3 other interventions for Pancreatic Cancer. Completed, enrolled 69 participants across 1 site.
Detailed Summary
The primary objective is to evaluate the efficacy of a combination of cetuximab with systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. The primary endpoint is actuarial one-year survival. The secondary objectives are: * To evaluate the local tumor response in patients treated with the above regimen. * To characterize the safety of the above regimen.
Study Details
Timeline
Interventions
500 mg/m\^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy.
Induction Therapy: 1 gm/m\^2 over 100 minutes every 2 weeks +/-1 day for 4 doses. Chemotherapy Maintenance: 1 gm/m\^2/week over 100 minutes weekly for 3 weeks then 1 week off.
Induction Chemotherapy: 100 mg/m\^2 over 120 minutes every 2 weeks +/-1 day for 4 doses.
Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m\^2 by mouth (PO) twice daily Monday-Friday throughout radiation.
Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.