Entry Detail
| General information | |
| Database: | DB00209 |
| Objective: | To evaluate the feasibility of administering sunitinib in combination with androgen deprivation therapy and externalbeam intensity modulated radiation therapy (XRT) in patients with localized highrisk prostate cancer. |
| Authors: | Corn PG |
| Title: | Sunitinib plus androgen deprivation and radiation therapy for patients with localized highrisk prostate cancer: results from a multiinstitutionalphase 1 study. |
| Journal: | Int J Radiat Oncol Biol Phys |
| Year: | 2013 |
| PMID: | 23541810 |
| Trial Design | |
| Clinical Trial Id: | NA |
| 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: | prostate cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 10 |
| Therapeutic Combination Content: | Sunitinib+androgen deprivation+radiation therapy |
| Study Type: | a multiinstitutionalphase I study. |
| Key Patients Feature: | men with localized adenocarcinoma of the prostate with cT2ccT4 or Gleason 810 or prostatespecific antigen >20 ng/mL received initial androgen deprivation (leuprolide 22.5 mg every 12 weeks plus oral bicalutamide 50 mg daily) for 48 weeks before |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | oral sunitinib 12.5, 25, or 37.5 mg daily for 4 weeks as leadin, then concurrently with and 4 weeks after XRT (75.6 Gy in 42 fractions to prostate and seminal vesicles). A 3+3 sequential doseescalation design was used to assess the frequency of doselimiting toxicity (DLT) and establish a maximal tolerated dose of sunitinib. |
| Primary End Point: | DLT, MDT |
| Secondary End Point: | NA |
| Patients Number: | 17 |
| Trial Results | |
| DLT_MTD: | 12.5 and 25mg dose levels was well tolerated;37.5 mg experienced a DLT (concurrent bicalutamide omitted);2 of 3 receiving concurrent therapy experienced DLTs during radiation enrolled at 37.5mg; Only 1 of 7 patients completed sunitinib at 37.5 mg daily, whereas 3 of 3 patients (25 mg as starting dose) and 3 of 4 patients (25 mg as reduced dose) completed therapy.RP2R:25mg daily |
| Objective Response Rate: | NA |
| 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 acute toxicities as described in Table 3 were fatigue, neutropenia, anemia and hypertension. The most common late toxicities were fatigue and hypertension occurring in 12% of patients, with Grade 1 fatigue in two patients, Grade 1 hypertension in one patient and Grade 2 hypertension in a second patient. |
| Conclusions: | The feasibility of combined vascular endothelial growth factor receptor (VEGFR)plateletderived growth factor receptor (PDGFR) inhibitor therapy, androgen deprivation, and radiation therapy for prostate cancer was established. Using a daily dosing regimen with leadin, concurrent, and postXRT therapy, the recommendedphase 2 dose of sunitinib is 25 mg daily. |