| General information |
| Database: | DB00549 |
| Objective: | hisphase II trial assessed temsirolimus, an inhibitor of mammalian target of rapamycin (mTOR), as secondline therapy in patients with metastatic transitional carcinoma of the urothelium (TCCU) after failure of platinum containing therapy. |
| Authors: | Gerullis H, et al |
| Title: | a phase II trial of temsirolimus in secondline metastatic urothelial cancer |
| Journal: | Med Oncol. |
| Year: | 2012 |
| PMID: | 22447503 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | temsirolimus
|
| Target: | Serine/threonineprotein kinase mTOR
|
| Cancer Type: | Urothelial Carcinoma |
| Cancer Subtype: | advanced transitional cell carcinoma of the urothelial tract |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | phase II trial |
| Key Patients Feature: | Eligible patients had to be 18 years or olderwith a minimum karnofsky performance status (KPS) of60 %. Pathologically documented and measurable locallyadvanced or metastatic TCCU of the urinary bladder orupper urinary tract with documented disease progressionafter firstline platinumbased therapy was required forentering the study. Prior surgical cure was not a requirement for being enrolled. Patients had to be diseasefreefrom other malignancies within the 2 years preceding studyentry except basalioma of the skin. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Temsirolimus was given i.v. at a dose of 25 mg in a weekly 30min intravenous infusion for 8 consecutive weeks. Premedication with 50 mg of intravenous dimetindenmaleat or a similar H1 blocker was given approximately 30 min prior to each weekly temsirolimus infusion as prophylaxis against allergic reactions |
| Primary End Point: | overall survival. |
| Secondary End Point: | time to disease progression, safety and QoL along treatment using the QLQC30 questionnaire |
| Patients Number: | 15 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | 2.5 months (77 days), |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 3.5 months (107 days) |
| Adverse Event(agent arm): | As Grade 3-4 adverse events, they observed fatigue (n = 2), leukopenia (n = 2) and thrombopenia (n = 2). All other adverse events were graded 1-2 in nature. |
| Conclusions: | Temsirolimus seems to have poor activity in patients with progressive metastasized TCCU after failure of platinum containing firstline therapy. |