A phase 2, single agent study of CI-1033 administered at two doses in ovarian cancer patients who failed platinum therapy

5054 Background: Ovarian cancer that is refractory to platinum-based therapies is a therapeutic challenge, particularly in the setting of erbB-1 and -2 receptor over- expression. CI-1033 is an irreversible, 4-anilinoquinazoline pan-erbB tyrosine kinase inhibitor with activity in a wide variety of human tumor xenografts, particularly erbB+ tumors including ovarian SK-OV-3. Methods: This study evaluated 50- and 200mg doses of CI-1033, given daily for 21 days repeated every 28 until disease progression in pts with platinum-refractory ovarian cancer. Primary eligibility criteria included disease progression following platinum therapy, measurable disease, and Karnofsky Performance Status (KPS) of 60–100. Baseline tumor erbB receptor profiles were determined by IHC staining retrospectively in 56 of the 105 pts. Endpoints included 1-yr progression-free survival (PFS) and overall survival (OS). Results: Between January and May of 2002, 105 patients were enrolled. Baseline characteristics were balanced between bot...