Protocol
10-106
Full Title
Phase I Trial of Gemcitabine and Split-Dose Cisplatin Plus Everolimus (RAD001) in Patients with Advanced Urothelial Cancer
Purpose
Gemcitabine and cisplatin are two standard chemotherapy drugs used to treat tumors of the urothelial tract. These drugs do not shrink tumors in all patients, however, and when they do, it is generally for a limited amount of time. Scientists are therefore seeking more effective ways to treat these cancers.
The purpose of this study is to evaluate the safety of gemcitabine and cisplatin plus everolimus at different dose levels in patients with advanced urothelial cancers that have grown or spread despite previous treatments. Urothelial cancers include those of the bladder, ureter, urethra, or renal pelvis.
Everolimus is a pill that inhibits a molecule called mTOR, which helps cancer cells grow. Laboratory studies have shown that everolimus appears to improve the activity of cisplatin against cancer cells. Everolimus is currently approved to treat advanced renal cell carcinoma; its use against other cancers is considered investigational.
Investigator
Co-Investigators
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of metastatic urothelial cancer.
- Patients may not have received treatment for metastatic disease.
- At least 1 year must have passed since completion of prior adjuvant or neoadjuvant chemotherapy and diagnosis of metastatic disease. Patients may not have received any anticancer therapies within 4 weeks of entering the study.
- Patients may not have received prior treatment with mTOR inhibitors.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Dean Bajorin at 646-422-4333.
Disease(s)
Bladder Cancer
Locations
ClinicalTrials.gov
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