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A Phase II Trial of Gemcitabine and Cisplatin plus Sorafenib in Chemotherapy-naïve Patients with Locally Advanced or Metastatic Urothelial Carcinoma
[Protocol 07-168]
- Full Title :
- PHASE II STUDY OF GEMCITABINE AND SPLIT-DOSE CISPLATIN (GC) PLUS SORAFENIB IN CHEMOTHERAPY-NAIVE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA
- Purpose :
Urothelial tumors include those arising in the bladder, urethra, ureter, or kidney. Gemcitabine and cisplatin are an effective and standard drug combination used to treat locally advanced and metastatic urothelial cancers. 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 these cancers.
New drugs have been developed to treat cancer by decreasing the blood supply to tumors, limiting the tumor's source of oxygen and nutrients and preventing the tumor from growing. Sorafenib is an example of a drug that works in this way. It is already approved for treating renal cell carcinoma and a form of liver cancer.
The purpose of this study is to evaluate the safety and effectiveness of combination treatment with gemcitabine, cisplatin, and sorafenib in patients with locally advanced or metastatic urothelial cancers who have not yet received systemic chemotherapy.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have locally advanced or metastatic urothelial cancers.
- Patients may not have previously received systemic chemotherapy.
- For patients who have had prior radiation therapy or major surgery, at least 4 weeks must have passed since completion of these treatments and entry into the study.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Matthew Milowsky at 646-422-4461.
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