drugset / Trial / NCT00714948

Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma

NCT00714948 ↗

NaSingle-groupOpen-labelTreatment

Summary

Standard chemotherapy drugs generally work by killing rapidly dividing cells in your body. Cancers cells are some of the most rapidly dividing cells and that is why chemotherapy can be effective in some patients. Gemcitabine and Cisplatin are an effective and standard drug combination used to treat locally advanced and metastatic urothelial cancer. However, these drugs do not shrink tumors in all patients and when they do, it is generally for a limited amount of time. This has led scientists to look for different ways to treat cancer. New drugs have been developed to treat cancer that work differently than standard chemotherapy drugs. These drugs attempt to decrease the blood supply to tumors. By doing so, this may limit the tumor's source of oxygen and nutrients and prevent the tumor from growing. Sorafenib is an example of a drug that works in this way. In some patients with advanced kidney cancer, sorafenib alone has been shown to slow the progression of their disease. The purpose of this study is to find out what effects, good and/or bad, the combination of gemcitabine, cisplatin, and sorafenib has on you and your cancer.

Timeline

Start
2008-07
Primary completion
2011-11
Completion
2011-11

Outcome

Outcome not reported

Stopped (Enrollment): “Lack of accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 35 mg/m2 —
Subject Gemcitabine Small molecule 1000 mg/m2 —
Subject Sorafenib Small molecule 400 mg Oral