Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium
The purpose of this study is to learn what effects, good and/or bad, Everolimus has on advanced urothelial cancer.
The goal of this clinical research study is to learn if the study drug Everolimus can shrink or slow the growth of urothelial cancer. The safety of this drug will also be studied. The patients physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Everolimus is safe and effective.
Metastatic Transitional Cell Carcinoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium|
- To measure the two-month PFS rate of Everolimus (RAD001) as determined by RECIST. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- To determine the safety and toxicity of Everolimus (RAD001) in this patient population. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
- To determine the response rate of Everolimus in patients with progressive urothelial cancer who have received prior cytotoxic chemotherapy. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- To assess markers for activated mTOR pathway (including phospho-S6 and phospho-4E BP1) in all pre-treatment tissue specimens and correlate with response to treatment and PFS. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Everolimus will be administered at a dose of 10 mg orally once daily continuously.
Everolimus (RAD001) is a novel oral derivative of rapamycin. Everolimus will be administered orally as a once-daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take Everolimus in the morning, at the same time each day. Everolimus should be taken by the patient in a fasting state or with no more than a light fat-free meal.
|United States, New Jersey|
|Memorial Sloan-Kettering at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan-Kettering at Mercy Medical Center|
|Rockville Centre, New York, United States|
|Memoral Sloan Kettering Cancer Center@Phelps|
|Sleepy Hollow, New York, United States|
|Principal Investigator:||Dean Bajorin, MD||Memorial Sloan-Kettering Cancer Center|