Abstract
2536 Background: TPI 287 is a novel taxane designed to avoid drug efflux by mdr-1. Preclinically, TPI 287 demonstrated activity against multiple human tumor xenografts, including those expressing mdr-1 and resistant to other taxanes. Methods: This was a phase I dose escalation study of TPI 287 administered weekly for 3 weeks followed by 1 week off. Treatment cohorts consisted of 3 pts and were expanded to 6 pts if dose-limiting toxicity (DLT) was seen; pts could remain on study until the development of progressive disease or an intolerable adverse event. The MTD was defined as the dose at which < 2/3 of pts experienced DLT. Results: 48 pts (M:F 25:23, median age 60, range 24 - 86) were enrolled in 7 dose levels ranging from 7 - 185 mg/m2. Pts’ cancers included colorectal (14); pancreatic and ovarian (4 each); gastroesophageal, HN and 1 pt each with basal cell, breast, cervical, endometrial, melanoma, osteosarcoma, renal, SCLC, thymus and thyroid All pts received ...
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