| General information |
| Database: | DB00939 |
| Objective: | To evaluate, in a phase 2 study, the safety and efficacy of induction gemcitabine, oxaliplatin, and cetuximab followed by selective capecitabinebased chemoradiation in patients with borderline resectable or unresectable locally advanced pancreatic cancer (BRPC or LAPC, respectively). |
| Authors: | Esnaola NF, et al |
| Title: | Phase 2 trial of induction gemcitabine, oxaliplatin, and cetuximab followed by selective capecitabinebased chemoradiation in patients with borderline resectable or unresectable locally advanced pancreatic cancer. |
| Journal: | Int J Radiat Oncol Biol Phys. |
| Year: | 2014 |
| PMID: | 24606850 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | pancreatic cancer |
| Cancer Subtype: | advanced pancreatic cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | gemcitabine, oxaliplatin, + cetuximab |
| Study Type: | Phase II trial |
| Key Patients Feature: | patients with borderline resectable or unresectable locally advanced pancreatic cancer (BRPC or LAPC, respectively). |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received gemcitabine and oxaliplatin chemotherapy repeated every 14 days for 6 cycles, combined with weekly cetuximab. patients were then restaged; "downstaged" patients with resectable disease underwent attempted resection. Remaining patients were treated with chemoradiation consisting of intensity modulated radiation therapy (54 Gy) and concurrent capecitabine; patients with borderline resectable disease or better at restaging underwent attempted resection. |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 39 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 10.4 months (95% CI 7.216.2 months) |
| Median OS A vs. C: | 11.8 months (95% CI 9.220.4 months) |
| Adverse Event(agent arm): | Twentysix of 37 patients (70.3%) had no grade 3 or higher toxicity during induction chemotherapy (toxicities experienced by the remaining patients are listed in Table 3). There was 1 grade 3 infusion reaction to oxaliplatin. In addition, there were 2 grade 3 cetuximabrelated acneiform rashes and 1 grade 4 cetuximabrelated infusion reaction (anaphylaxis). There were 9 grade 3 and 2 grade 4 hematologic toxicities. Finally, there were 9 grade 34 electrolyte disturbances during induction chemotherapy. |
| Conclusions: | This regimen was well tolerated in patients with BRPC or LAPC, and almost onethird of patients undertheynt R0 resection. Although OS for the entire cohort was comparable to that in historical controls, PFS and OS in patients with BRPC andor who undertheynt R0 resection was markedly improved |