Phase 2 clinical trial of ixabepilone in metastatic cervical carcinoma.

5593 Background: Ixabepilone is a microtubule-stabilizing agent approved for metastatic breast cancer. Preclinical data indicates activity in taxane-sensitive and resistant cells. Metastatic cervical carcinoma (mCC) has a poor prognosis and no accepted second line therapies. This study assessed the efficacy and safety of Ixabepilone in previously treated mCC. Methods: Patients with histologically confirmed mCC and at least one prior regimen received ixabepilone [6mg/m2/d X 5d] every 21 days. Primary endpoint was PFS by RECIST. Secondary endpoints were response rate, overall survival, and safety. We calculated the rate of tumor growth (g) as an additional efficacy measure. Results: Forty-one patients were enrolled; thirty four tumors were squamous. The median number of prior therapies was 2 (range1-6). Four patients (9.7%) had partial responses. Median time to progression in months was 2.3 for all, 3.84 for taxane-naive and 2.03 for taxane pre-treated patients (p=0.13). Consistent with this we found the ra...