Entry Detail
| General information | |
| Database: | DB00041 |
| Objective: | Although the taxanes represent the most active agents for the firstline treatment of metastatic hormonerefractory prostate cancer (HRPC), most patients eventually progress while receiving taxanebased treatments. No agents are approved for secondline therapy in HRPC, but common standard practice for the oncologists is to treat patients also after docetaxel failure. |
| Authors: | Di Lorenzo G, et al |
| Title: | Combination of bevacizumab and docetaxel in docetaxelpretreated hormonerefractory prostate cancer: a phase 2 study. |
| Journal: | Eur Urol |
| Year: | 2008 |
| PMID: | 18276061 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab |
| Target: | Vascular endothelial growth factor Epidermal growth factor receptor |
| Cancer Type: | prostate cancer |
| Cancer Subtype: | castration resistant prostate cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | bevacizumab +docetaxel |
| Study Type: | a phase II Study |
| Key Patients Feature: | patients with HRPC who had been previously treated with docetaxel CT as firstline treatment, disease progression (biochemical or objective) to previous CT, and a treatmentfree interval from previous CT of more than and equal to 6 wk. |
| Biomarker: | prostatespecific antigen (PSA) |
| Biomark Analysis: | Serum prostatespecific antigen levels were prospectively monitored as a biomarker for cancer activity. |
| Control Group Info: | single arm |
| Treatment Info: | Patients received 10 mg/kg bevacizumab intravenously on day 1 in combination with 60 mg/m2 docetaxel intravenously on day 1 repeated every 21 d. |
| Primary End Point: | assessment of response rate (biochemical and objective response every 2 and 3 cycles, respectively). |
| Secondary End Point: | toxicity, PFS, and overall survival. |
| Patients Number: | 20 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | Eleven patients (55%) had major prostatespecific antigen (PSA) responses, and 3 (37.5%) had objective responses. Seven major PSA responses were recorded in the same patients who had reported a >50% PSA decrease after firstline docetaxel. however, four major PSA responses were observed in patients previously nonresponsive to docetaxel alone. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4 mo (95% confidence interval [95%CI], 2-6) |
| Median OS A vs. C: | 9 mo (95%CI, 4-12.5) |
| Adverse Event(agent arm): | treatment was well tolerated. No toxic deaths occurred. The most important grade 3 toxicities included neutropenia in three patients. Grade 3 nonhematologic toxicities included nausea/vomiting in two patients) and peripheral neuropathy in one. Grade 4 toxicity was limited to neutropenia (one patient) and thrombocytopenia (one patient) |
| Conclusions: | Their results show that the combination of bevacizumab and docetaxel is active and well tolerated. Continued investigation of bevacizumab with cytotoxic chemotherapy is warranted in HRPC. |