Phase II Trial of RAD001 (Everolimus) in Previously Treated Small Cell Lung Cancer
This is a phase II, two-stage, open-label, single-agent study of the experimental drug
RAD001 (everolimus) in patients with previously treated small cell lung cancer. Patients
may have received up to 2 prior chemotherapy regimens for small cell lung carcinoma, but no
prior therapy with an m-TOR inhibitor. RAD001 will be administered orally at a dose of 10
mg daily. A cycle will be defined as 3 weeks of study drug administration, and patients
will have tumor measurements every 2 cycles. Study participation will continue until
disease progression or intolerable toxicities. In addition, in patients who consent,
archival tumor tissue (paraffin block from original biopsy) will be collected for research
purposes.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the proportion of previously treated small cell lung cancer (SCLC) patients whose disease has not progressed following 6-weeks (2 cycles) of treatment with RAD001.
Two cycles of treatment with RAD001 (~6 weeks)
Yes
Ahmad Tarhini, MD, PhD
Principal Investigator
University of Pittsburgh
United States: Food and Drug Administration
06-049
NCT00374140
October 2006
November 2012
Name | Location |
---|---|
UPMC Cancer Center - Upper St. Clair | Pittsburgh, Pennsylvania 15243 |
UPMC Cancer Center - Uniontown | Uniontown, Pennsylvania 15401 |
UPMC Cancer Center - Teramana Cancer Center - Steubenville | Steubenville, Ohio 43952 |
UPMC Cancer Center - Beaver | Beaver, Pennsylvania 15009 |
UPMC Cancer Center - Clairton | Clairton, Pennsylvania 15025 |
UPMC Cancer Center - Oakbrook Commons - Greensburg | Greensburg, Pennsylvania 15601 |
UPMC Cancer Center - Arnold Palmer Pavilion - Greensburg | Greensburg, Pennsylvania 15601 |
UPMC Cancer Center - Indiana | Indiana, Pennsylvania 15701 |
UPMC Cancer Center - John P. Murtha Pavilion - Johnstown | Johnstown, Pennsylvania 15901 |
UPMC Cancer Center - McKeesport | McKeesport, Pennsylvania 15132 |
UPMC Cancer Center - Monroeville | Monroeville, Pennsylvania 15146 |
UPMC Cancer Center - Sewickley Medical Oncology/Hematology Group | Moon Township, Pennsylvania 15108 |
UPMC Cancer Center - New Castle | New Castle, Pennsylvania 16105 |
UPMC Cancer Center - Passavant | Pittsburgh, Pennsylvania 15237 |
UPMC Cancer Center - St. Margaret's | Pittsburgh, Pennsylvania 15215 |
UPMC Cancer Center - Mercy | Pittsburgh, Pennsylvania 15219 |
University of Pittsburgh Cancer Institute - Hillman Cancer Center | Pittsburgh, Pennsylvania 15232 |
UPMC Cancer Center - Washington | Washington, Pennsylvania 15301 |
UPMC Cancer Center - North Hills | Wexford, Pennsylvania 15090 |