Small Cell Lung Cancer Clinical Trial
Official title:
Phase I/II Study of Carboplatin and Etoposide in Combination With Vorinostat for Patients With Extensive Stage Small Cell Lung Cancer
The Phase I portion of the study is to assess the maximum tolerated dose of vorinostat when combined with carboplatin plus etoposide. The Phase II portion is to determine progression-free survival among patients with extensive disease small cell lung cancer receiving carboplatin plus etoposide with vorinostat.
Vorinostat inhibits growth and induces apoptosis in various human carcinoma cells.
Furthermore, it affects the expression of various genes that are necessary for proliferation
of cancer cells. Vorinostat also appears to block angiogenic signaling. Pre-treating four
human cancer cell lines (including a brain tumor line) with vorinostat increased the killing
efficiency of etoposide, ellipticine, doxorubicin, or cisplatin, but not of the topoisomerase
I inhibitor camptothecin 13. Topoisomerase II is a ubiquitous nuclear enzyme that is involved
in DNA replication, transcription, chromosome segregation, and apoptosis. It is the target
for several anti-cancer drugs including etoposide. Treatment with HDAC inhibitors induces
expression of topoisomerase II in cancer cells and enhances the sensitivity to etoposide 14.
Early phase clinical trials have demonstrated single agent anti-cancer activity with
vorinostat. In our study, combination of vorinostat with carboplatin and paclitaxel,
demonstrated promising anticancer activity against NSCLC, including histological subsets of
patients whose tumors demonstrated neuroendocrine differentiation 8. For all these reasons,
vorinostat is a rational choice to combine with the regimen of carboplatin and etoposide for
evaluation in patients with SCLC-ED.
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