Phase I evaluation of paclitaxel poliglumex (PPX) administered weekly for patients with advanced cancer

2043 Background: Weekly paclitaxel administration compared to Q3 week schedules may offer an efficacy benefit in patients with metastatic breast cancer (Proc ASCO; 2004, Abstract 512), although the benefit in NSCLC is less clear (Cancer, 97:2480, 2003; JCO 15:1, 1997). Paclitaxel poliglumex (XYOTAX) is a macromolecular drug conjugate that links paclitaxel with a biodegradable polymer, poly-L-glutamic acid. PPX is water soluble and can be administered as a 10 minute infusion. Eliminating the need for CremophorEL reduces the risk of hypersensitivity reactions, even without premedication. This study is designed to determine the MTD of PPX when administered weekly to patients (pts) with solid tumors. Methods: Escalating doses of weekly PPX are administered to pts who have received no extensive myelosuppressive regimens (defined as < 2 alkylator containing regimens) and have < grade 1 neuropathy. Each cycle consists of 6 weekly treatments with extended pharmacokinetic (PK) samples for PPX and free paclitaxel b...