Entry Detail
| General information | |
| Database: | DB00477 |
| Objective: | To prospectively investigate the safety and efficacy of axitinib in downsizing tumors in patients with nonmetastatic biopsyproven clear cell renal cell carcinoma (ccRCC). |
| Authors: | Karam JA, et al |
| Title: | Phase 2 trial of neoadjuvant axitinib in patients with locally advanced nonmetastatic clear cell renal cell carcinoma. |
| Journal: | Eur Urol. |
| Year: | 2014 |
| PMID: | 24560330 |
| Trial Design | |
| Clinical Trial Id: | NCT01263769 |
| Agent: | axitinib |
| Target: | Macrophage colonystimulating factor 1 Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | clear cell renal carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a prospective, singlecenter, openlabel, nonrandomizedphaseII study |
| Key Patients Feature: | clinical stage T2T3b (using AJCC 2010(4))without any radiographic evidence of nodal or distant metastases, clear cell histology onpretreatment biopsy of the primary renal tumor, tumor amenable for curative surgery, ECOGperformance status(5) of 0 or 1, adequate renal, liver, and bone marrow function, and did nothave any other cancers in the 5 years preceding diagnosis of their renal cancer. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received axitinib 5mg for up to 12 wk. Axitinib was continued until 36h prior to surgery. Patients underwent partial or radical nephrectomy after axitinib therapy. |
| Primary End Point: | objective response rate prior to surgery |
| Secondary End Point: | safety, tolerability, and quality of life. |
| Patients Number: | 24 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | Eleven patients experienced a partial response by RECIST; 13 had stable disease. There was no progression of disease while on axitinib. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most common Aes were hypertension, fatigue, oral mucositis, hypothyroidism, and handfoot syndrome. Postoperatively, 2 grade 3 and 13 grade 2 complications were noted. No grade 4 or 5 complications occurred. |
| Conclusions: | Axitinib was clinically active and reasonably well tolerated in the neoadjuvant setting in patients with locally advanced nonmetastatic ccRCC. |