Entry Detail
| General information | |
| Database: | DB00211 |
| Objective: | Thisphase 1/2 study assessed sunitinib combined with docetaxel (Taxotere) and prednisone in chemotherapynaive metastatic, castrationresistant prostate cancer (mCRPC) patients. |
| Authors: | Zurita AJ, |
| Title: | Sunitinib in combination with docetaxel and prednisone in chemotherapynaive patients with metastatic, castrationresistant prostate cancer: a phase 1/2 clinical trial. |
| Journal: | Ann Oncol. |
| Year: | 2012 |
| PMID: | 21821830 |
| Trial Design | |
| Clinical Trial Id: | NCT00137436 |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | prostate cancer |
| Cancer Subtype: | advanced castrationresistant prostate cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Sunitinib+docetaxel+prednisone |
| Study Type: | a phase I/II clinical trial |
| Key Patients Feature: | chemotherapynaive male patients with metastatic, castrationresistant prostate cancer |
| Biomarker: | PSA |
| Biomark Analysis: | Serum prostatespecific antigen levels were prospectively monitored as a biomarker for cancer activity. |
| Control Group Info: | single arm |
| Treatment Info: | 25 patients in four dose escalation cohorts received 3week cycles of sunitinib (2 weeks on, 1 week off), docetaxel and prednisone, preceded by a 4week sunitinib 50 mg/day lead in. RP2D was evaluated in 55 additional patients. |
| Primary End Point: | prostatespecific antigen (PSA) response rate. |
| Secondary End Point: | NA |
| Patients Number: | 80 |
| Trial Results | |
| DLT_MTD: | Onephase 1 doselimiting toxicity occurred (grade 3 hyponatremia). The RP2D was sunitinib 37.5 mg/day, docetaxel 75 mg/m(2) and prednisone 5 mg b.i.d. |
| Objective Response Rate: | confirmed PSA responses occurred in 31 patients [56.4% (95% confidence interval 42.369.7)];Among 33 assessable patients, 14 (42.4%) had confirmed partial response. |
| Disease Control Rate: | Fortyone patients (75%) were treated >3 months, 12 (22%) completed the study (16 cycles) and 43 (78%) discontinued (36% for disease progression and 27% adverse events). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 12.6 months |
| Median OS A vs. C: | 21.7 months |
| Adverse Event(agent arm): | The most frequent treatmentrelated grade 3/4 adverse events were neutropenia (53%; 15% febrile) and fatigue/asthenia (16%). |
| Conclusions: | This combination was moderately well tolerated, with promising response rate and survival benefit, justifying further investigation in mCRPC. |