| General information |
| Database: | DB00906 |
| Objective: | Angiogenesis inhibition has emerged as a potentially promising treatment strategy for neuroendocrine tumors. 2Methoxyestradiol (2ME2; Panzem( )) is a natural derivative of estradiol with demonstrated antiangiogenic activity in animal models. they performed a prospective, phase II study of 2ME2, administered in combination with bevacizumab, in patients with advanced carcinoid tumors. |
| Authors: | Kulke MH, et al |
| Title: | A prospectivephase II study of 2methoxyestradiol administered in combination with bevacizumab in patients with metastatic carcinoid tumors. |
| Journal: | Cancer Chemother Pharmacol. |
| Year: | 2011 |
| PMID: | 20960192 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | advanced solid tumors |
| Cancer Subtype: | advanced solid tumors |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | 2methoxyestradiol administered + bevacizumab |
| Study Type: | A prospectivephase II study |
| Key Patients Feature: | All patients were required to have histologically documented, locally unresectable or metastatic carcinoid neuroendocrine tumor. Patients with small cell carcinoma or pancreatic endocrine tumors were not eligible |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts were treated with 2ME2, administered orally at a dose of 1, 000 mg four times daily. Patients also received bevacizumab 5 mg/kg intravenously every 2 weeks. |
| Primary End Point: | evidence of toxicity, tumor response, and survival. |
| Secondary End Point: | NA |
| Patients Number: | 31 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | 94% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 11.3 months |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most frequently reported treatment emergent adverse events were gastrointestinal and included nausea (18/31 any grade, 58%) and diarrhea (14/31 any grade, 45%). |
| Conclusions: | 2ME2 and bevacizumab can be safely administered to patients with advanced carcinoid tumors. While major tumor regression was not observed with this regimen, the encouraging median progression free survival time suggests that this regimen has some degree of antitumor activity and supports the further investigation of angiogenesis inhibitors in this disease |