| General information |
| Database: | DB00668 |
| Objective: | The objective of the current study was to evaluate the contribution of a monoclonal antibody against EGFR, nimotuzumab, to standard gemcitabine therapy. |
| Authors: | Su D, et al |
| Title: | Efficacy of nimotuzumab plus gemcitabine usage as firstline treatment in patients with advanced pancreatic cancer. |
| Journal: | Tumour Biol. |
| Year: | 2014 |
| PMID: | 24142531 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | nimotuzumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | pancreatic cancer |
| Cancer Subtype: | pancreatic cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | nimotuzumab+ gemcitabine |
| Study Type: | a nonrandomized, nonblindedsinglearm study |
| Key Patients Feature: | at least 18 years of age or older, histologically and cytologically confirmed adenocarcinomaof the pancreas with distant metastases or locally advancedunresectable disease, presence of either measurable orevaluable disease, Karnofsky performance statusmore than and equal to 70 %, andadequate organ function defined as an absolute neutrophilcountmore than and equal to 1, 500/¦ÌL, platelet count more than and equal to 100, 000/¦ÌL, serumbilirubinless than and equal to 2 mg/dL, serum albuminmore than and equal to 2.5 g/dL, serum aspartateaminotransferase (AST) and alanine aminotransferase(ALT)less than and equal to 2¡Á the upper limit of normal for the institution (5¡Á ifdue to hepatic metastases), and creatinineless than and equal to 5¡Á the upper limitof normal for the institution or creatinine clearancemore than and equal to 60 mL/min. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Gemcitabine was administered intravenously at a dose of 1, 000 mg/m2 over 30 min. During the first 8 weeks, gemcitabine wasadministered weekly for 7 weeks followed by 1week holiday. In all remaining cycles, gemcitabine was administered for3 weeks followed by a week of holiday. Nimotuzumab was delivered intravenously once per week at a loading dose of 200 mg over 60 min. |
| Primary End Point: | overall survival |
| Secondary End Point: | progression free survival, objective response, and adverse side effects |
| Patients Number: | 18 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | 0.556 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.71 months (95 % CI, 2.526 to 4.902) |
| Median OS A vs. C: | 9.29 months (95 % CI, 5.499 to 13.072) |
| Adverse Event(agent arm): | Of all the patients, 88.8 % had at least one adverse side effect; however, no grade 4 adverse side effect was reported. |
| Conclusions: | Nimotuzumab as a highpurity humanized monoclonal antibody with favorable safety profile, its value in the treatment of pancreatic cancer along with gemcitabine, particularly in the comprehensive treatment of advanced pancreatic cancer, is appealing for further prospective randomized largescale clinical trials. |