Entry Detail
| General information | |
| Database: | DB00563 |
| Objective: | Thisphase II trial was conducted to determine the efficacy and tolerability of sorafenib for the treatment of patients with metastatic urothelial cancer (UC) who had not had prior chemotherapy for advanced disease. |
| Authors: | Sridhar SS, et al |
| Title: | a phase II trial of sorafenib in firstline metastatic urothelial cancer: a study of the PMHphase II Consortium. |
| Journal: | Invest New Drugs. |
| Year: | 2011 |
| PMID: | 20191303 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | Urothelial Carcinoma |
| Cancer Subtype: | transitional cell cancer of the urothelium (bladder, ureter, or renal pelvis) |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a multiinstitutionalphase II study |
| Key Patients Feature: | patients had to be more than and equal to 18 years of age, haveadequate organ function, ECOG Performance Status (PS) 0 or1, life expectancy more than and equal to 3 months, and confirmed transitional cellcancer of the urothelium (bladder, ureter, or renal pelvis) withmeasureable disease. Prior systemic therapy for advanceddisease was not permitted. Prior neoadjuvant or adjuvantchemotherapy or radiation treatment was permitted ifcompleted more than and equal to 4 weeks prior to study entry. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts were treated with sorafenib 400 mg twice daily on a continuous basis until progression or unacceptable toxicity. |
| Primary End Point: | objective tumor response rate |
| Secondary End Point: | rate of prolonged stable disease (>3 months), time to progression, median and 1 yr survival and safety and tolerability. |
| Patients Number: | 14 |
| Trial Results | |
| DLT_MTD: | The most frequent adverse events (AE) werefatigue in 16/17 pts, anorexia in 12/17 pts, constipation in11/17 pts and abdominal pain in 11/17 pts. The most commongrade 3+ adverse eventswere abdominal pain in 4/17 pts, backpain in 4/17 pts handfoot reaction in 3/17 pts and bladderinfection in 3/17 pts. |
| Objective Response Rate: | There were noobjective responses. Only one patient had stable disease byRECIST criteria and remained on treatment more than3 months. Three patients had stable disease by RECISTcriteria but were on treatment less than 3 months due toprogressive disease (PD) or adverse events (AE). |
| Disease Control Rate: | NA |
| Median Time to Progression: | 1.9 months (range 0.7-8.7 months) |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 5.9 months |
| Adverse Event(agent arm): | The most common grade 3+ toxicities were abdominal pain, back pain, handfoot reaction and bladder infection. |
| Conclusions: | Sorafenib does not show sufficient activity as a single agent in firstline metastatic urothelial cancer to warrant further investigation. |