STA9090: Phase I Trial of Ganetespib, Capecitabine, and Radiation in Rectal Cancer
Patients with rectal cancer who meet the eligibility criteria will be offered to enroll on
the study. As part of the study patients will receive the standard of care capecitabine (825
mg/m2 by moth twice daily) and radiation. Patients will start on ganetespib (STA9090) at a
set dose level.
The treatment consists of two parts. In the first part patients will receive ganetespib at
full dose twice a week through the vein for two weeks. At the end of two weeks, a biopsy of
the tumor will be performed to evaluate the effect of the drug on the tumor. In the second
phase, the patients will receive capecitabine, radiation and ganetespib at a specified dose
level for 5 to 6 weeks. After completion of this phase patient will have surgery to remove
the tumor. Each three patients will be treated at a specified dose level. Patients will be
monitored at least once a week for side effects. If there are no side effects in three
consecutive patients then the investigators will treat the next three patients at a higher
dose level.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Tumor response and disease progression will be evaluated in this study using the international criteria proposed by the RECIST.
Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria.
8 weeks
Yes
Roberto Diaz, MD
Principal Investigator
Emory University
United States: Institutional Review Board
STA 9090
NCT01554969
May 2012
November 2014
Name | Location |
---|---|
Emory University Winship Cancer Institute | Atlanta, Georgia 30322 |