NCT01182168

Gemcitabine and Split-Dose Cisplatin Plus Everolimus (RAD001) in Patients With Advanced Solid Tumor Malignancies

Phase I Trial of Gemcitabine and Split-Dose Cisplatin Plus Everolimus (RAD001) in Patients With Advanced Solid Tumor Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety of gemcitabine and cisplatin plus Everolimus (also called RAD001) at different dose levels. We want to find out what effects, good and/or bad, this treatment has on you and your cancer. Gemcitabine and cisplatin are standard chemotherapy drugs that are commonly used to treat advanced urothelial cancer. Everolimus is a pill that works by shutting down some of the pathways in cancer cells that make tumors grow. Laboratory studies have shown that Everolimus appears to improve the activity of cisplatin against cancer cells.

Conditions

• Bladder Cancer
• Renal Pelvis Cancer
• Ureter Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine and split-dose cisplatin plus escalating doses of continuous Everolimus (RAD001)	Patients will receive gemcitabine IV and cisplatin IV on days 1 and 8. Everolimus orally will be administered continuously (one cycle = 21 days). Everolimus will be escalated at the following dose levels: 5mg every-other-day, 5mg daily, and 10mg daily. Patients will receive a total of 6 cycles of gemcitabine and cisplatin in combination with Everolimus unless disease progression or unacceptable toxicity occurs.

Timeline

• Start date: 2010-08-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2010-08-16
• Last updated: 2016-03-31

Locations

1 site across 1 country: United States