| General information |
| Database: | DB00946 |
| Objective: | The EGFR/Akt/NF¦ÊB signalling pathway is frequently deregulated in pancreatic cancer and contributes to cell growth, metastasis and chemoresistance. An isoflavone, genistein, inactivates Akt and NF¦ÊB and enhances the antitumor activity of erlotinib and gemcitabine in experimental systems of pancreas cancer. Thisphase II study was undertaken to determine the effects of adding isoflavone to a regimen of gemcitabine and erlotinib on survival in patients with advanced pancreatic cancer |
| Authors: | ElRayes BF, et al |
| Title: | a phase II study of isoflavones, erlotinib, and gemcitabine in advanced pancreatic cancer. |
| Journal: | Invest New Drugs. |
| Year: | 2011 |
| PMID: | 20107864 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | pancreatic cancer |
| Cancer Subtype: | advanced pancreatic cancer. |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | isoflavones, erlotinib, + gemcitabine |
| Study Type: | a phase II study |
| Key Patients Feature: | Eligibility included previously untreated patients with advanced pancreatic adenocarcinoma. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received gemcitabine 1, 000 mg/m2 on days 1, 8, and 15, and erlotinib 150 mg once daily P.O. on day 1 to day 28. Soy isoflavones (Novasoy ) were administered at a dose of 531 mg twice daily P.O. starting day 7 until the end of study participation. |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 20 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 5.2 months (95% CI, 4.6N/A months) |
| Adverse Event(agent arm): | One patient did not receive any treatment and was not evaluated for toxicity. No treatmentrelated deaths were reported. No toxicities due to soy isoflavones were observed. Table 2 summarizes the grade 3 and 4 toxicities observed on the study. One episode of grade 4 neutropenia was observed. Ten patients had grade 2 skin rash. One patient developed a grade 3 cellulitis. Six patients required hospitalization (three deep venous thrombosis/pulmonary embolism, one for each dehydration, cellulitis, and thrombocytopenia). |
| Conclusions: | The addition of soy isoflavones to gemcitabine and erlotinib did not appear to increase the survival of patients with advanced pancreatic cancer |