Entry Detail
| General information | |
| Database: | DB00042 |
| Objective: | A randomized, placebocontrolled study based on preclinical and clinical data that supports the potential role of vascular endothelial growth factor in prostate cancer was performed to evaluate the addition of bevacizumab to standard docetaxel and prednisone therapy in patients with metastatic castrationresistant prostate cancer (mCRPC). |
| Authors: | Kelly WK, et al |
| Title: | Randomized, doubleblind, placebocontrolledphase III trial comparing docetaxel and prednisone with or without bevacizumab in men with metastatic castrationresistant prostate cancer: CALGB 90401. |
| Journal: | J Clin Oncol |
| Year: | 2012 |
| PMID: | 22454414 |
| Trial Design | |
| Clinical Trial Id: | NCT00110214 |
| Agent: | bevacizumab |
| Target: | Vascular endothelial growth factor Epidermal growth factor receptor |
| Cancer Type: | prostate cancer |
| Cancer Subtype: | advanced castrationresistant prostate cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | bevacizumab+ docetaxel + prednisone |
| Study Type: | a Randomized, doubleblind, placebocontrolledphase III trial |
| Key Patients Feature: | Patients with chemotherapynaive progressive mCRPC with Eastern Cooperative Oncology Group performance status less than and equal to 2 and adequate bone marrow, hepatic, and renal function |
| Biomarker: | PSA |
| Biomark Analysis: | Serum prostatespecific antigen levels were prospectively monitored as a biomarker for cancer activity. |
| Control Group Info: | Docetaxel and Prednisone+ placebo |
| Treatment Info: | patients were randomly assigned to receive docetaxel 75 mg/m(2) intravenously (IV) over 1 hour for 21 days plus prednisone 5 mg orally twice per day (DP) with either bevacizumab 15 mg/kg IV every 3 weeks (DP + B) or placebo. |
| Primary End Point: | overall survival |
| Secondary End Point: | progression free survival (PFS), 50% decline in prostatespecific antigen, objective response (OR), and toxicity. |
| Patients Number: | 1050 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | ORR (49.4% v 35.5%; P = .0013), PSA decline more than and equal to 50% (69.5% v 57.9%; P < .001) |
| Disease Control Rate: | PSA decline more than and equal to 50% (69.5% v 57.9%; P < .001) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The median OS for patients given DP + B was 22.6 months compared with 21.5 months for patients treated with DP (hazard ratio, 0.91; 95% CI, 0.78 to 1.05; stratified logrank P = .181). |
| Median OS A vs. C: | The median OS for patients given DP + B was 22.6 months compared with 21.5 months for patients treated with DP (hazard ratio, 0.91; 95% CI, 0.78 to 1.05; stratified logrank P = .181). |
| Adverse Event(agent arm): | The median OS for patients given DP + B was 22.6 months compared with 21.5 months for patients treated with DP (hazard ratio, 0.91; 95% CI, 0.78 to 1.05; stratified logrank P = .181). |
| Conclusions: | Despite an improvement in PFS and OR, the addition of bevacizumab to docetaxel and prednisone did not improve OS in men with mCRPC and was associated with greater toxicity |