The Section is developing a novel treatment approach for advanced stage newly diagnosed disease, which involves adding taxol to what is the currently accepted standard of care. This regimen is taxol, cisplatin and cytoxan, given with G-CSF support. The first aspect of this sub-project is to determine the optimal way in which to dose intensify the taxol and cisplatin components of the regimen. Once this is completed, a phase II study will commence to assess the potential utility of the regimen. As of this writing, 20 patients have been placed on study; and preliminary findings were presented at the annual ASCO meetings in May of this year. Up to the dose levels of: taxol 250 mg/m2, cisplatin 100 mg/m2, and cytoxan 750 mg/m2, full doses of therapy can be administered on time for up to six cycles of treatment. The objective response rate in evaluable patients is 84%. No dose limiting toxicities have been seen through this dose level, which has been completed. Currently, patients are being accrued at the next dose level, which differs in that the cisplatin dose is 125 mg/m2. The target cisplatin dose is based on the previously published maximally tolerated platinum dose intensity without CSF's that was recently published by this group.
