The future of phase II trials.

The CTEP database of phase II, or phase I/II clinical trials between 2000 and 2005 (exclusive for ovarian cancer), with investigational agents where CTEP holds the INDwas reviewed. Between 2000 and 2005, CTEP received 100 LOIs and 36 were approved. In addition, in the last three years, CTEP has sent out 14 solicitations for high priority investigational agents and seven of these solicitations included requests for phase II trials in ovarian carcinoma. Solicitations for agents included depsipeptide (NSC 630176), a bicyclic inhibitor of HDAC, BAY 43-9006 (Sorafenib) inhibitor of Raf kinase, GW572016 am inhibitor of EGFR, Triapine combination (NSC 663249) inhibitor of robonucleotide reductase, AZD2171 (NSC 732208) inhibitor of VEGF-TK, E7389 (NSC 707389), AZD0530 (NSC 735464) inhibitor of c-Src, and Bcr-Abl. These solicitations were heavily weighted toward novel targeted agents. CTEP has approved a median of six trials with a range of two to nine in each of the last five years. There are 21 CTEPsponsored trials using IND agents currently accruing patients today. The administrative process regarding development and activation of protocols was reviewed. Cancer centers usually develop a protocol in a median of about two months. The cooperative groups have somewhat slower median time of four to six months. This likely reflects the complicated internal