| General information |
| Database: | DB00667 |
| Objective: | This trial was designed to assess efficacy and safety of erlotinib with sorafenib in the treatment of patients with advanced pancreatic adenocarcinoma. |
| Authors: | Cardin DB, et al |
| Title: | Phase II trial of sorafenib and erlotinib in advanced pancreatic cancer. |
| Journal: | Cancer Med. |
| Year: | 2014 |
| PMID: | 24574334 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | sorafenib and erlotinib
|
| Target: | NA
|
| Cancer Type: | pancreatic cancer |
| Cancer Subtype: | advanced pancreatic adenocarcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | sorafenib + erlotinib |
| Study Type: | Phase II trial |
| Key Patients Feature: | Patients with a histologic diagnosis of advanced (locallyadvanced and unresectable or metastatic) pancreaticadenocarcinoma who received no more than one priorsystemic therapy for advanced disease were eligible forthis trial. Additional eligibility criteria included measurabledisease by RECIST 1.0 criteria; age more than and equal to 18; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;adequate bone marrow, hepatic and renal function asdefined by absolute neutrophil count (ANC) of more than and equal to 1500/mm3, platelet count more than and equal to 100, 000/mm3, total bilirubin less than and equal to 1.59the upper limit of normal (ULN), alanine aminotransferase(ALT) and aspartate aminotransferase (AST) less than and equal to 2.59 theULN (or less than and equal to 59 the ULN for patients with liver involvement), and creatinine less than and equal to 1.59 ULN. Coagulation parameters were required to be within normal limits for patientsnot on chronic anticoagulation; patients on warfarin orheparin were allowed to participate but with close monitoring. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | retrospective analysis |
| Primary End Point: | safety and efficacy |
| Secondary End Point: | NA |
| Patients Number: | 36 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | Disease control rate was 24% (stable disease) at 8 weeks. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Eightweek PFS rate observed was 46% (95% CI: 0.32-0.67) Fourmonth PFS rate was 16.7% (95% CI: 0.08-0.346). |
| Median OS A vs. C: | 99.5 days (95% CI: 71-188) or ~3.3 months |
| Adverse Event(agent arm): | Grade 3 toxicities of this regimen included fever, anemia, diarrhea, dehydration, rash, and altered liver function. |
| Conclusions: | This study did not meet the primary endpoint, and this combination will not be further pursued. In this small retrospective analysis, the proteomic classification was significantly associated with clinical outcomes and is being further evaluated in ongoing studies. |