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Clinical Trial 16664
A Phase I-II Study of PTX-200 Plus Sequential Weekly Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide in Patients with Metastatic and Locally Advanced Breast Cancer
The purpose of the trial is to determine the appropriate dose of PTX-200 to use in combination with paclitaxel in patients with metastatic breast cancer and other cancers, and whether it enhances the effectiveness of chemotherapy in patients with locally advanced breast cancer treated with chemotherapy prior to surgery.
Primary Objectives: To determine the recommended phase II dose of triciribine given on days 1, 8, and 15 every 28 days (maximum of 9 doses) when combined with weekly paclitaxel (80 mg/m^2) for 12 weeks in patients with metastatic breast cancer (phase I portion of trial) To determine the pathologic complete response rate (including breast and breast plus axillary nodes) after sequential weekly paclitaxel triciribine followed by doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks x 4 cycles in patients with clinical stage IIB-IIIC breast cancer (phase II portion). To determine the feasibility and safety of the combination of sequential weekly paclitaxel plus triciribine, followed by doxorubicin/cyclophosphamide (phase II portion) Secondary Objectives: Laboratory objectives: To correlate pre-treatment levels of ErbB1,2,3,4, and phosphorylated levels of Akt, STAT3, Erk1/2 to clinical response (Sebti lab - phase I or II portion). To correlate the percent decrease in the levels of phospho-Akt(S473), phospho-S6 (S235-236), phospho-PRAS40 (Thr246), PTEN, Stathmin, PDK1, Cyclin D1, phospho-STAT3, Rho C, and phospho-Erk 1-2 with clinical response rates, percent inhibition of proliferation (Ki-67) and percent induction of apoptosis (Tunel) (Sebti lab - phase I or II portion).