Phase (ph) 2 study of bortezomib ± docetaxel in previously treated patients (pts) with advanced non-small cell lung cancer (NSCLC): Preliminary results

7107 Background: Tax, a microtubule stabilizer, is active against NSCLC. Bortezomib (VELCADE), a reversible proteasome inhibitor, has demonstrated activity against NSCLC in ph 1 trials. Vc + Tax had manageable, non-additive toxicities in a prior ph 1 trial. Vc + Tax is more potent than either agent alone in tumor models in mice. Methods: The primary objective of this randomized, multicenter, open-label, phase 2 study was determining tumor response to Vc ± Tax. Secondary objectives were safety, tolerability, survival, pharmaco-kinetics, -dynamics, and -genomics. Patients (pts) ≥18 yr, stage IIIB or IV NSCLC, KPS ≥70, 1 prior chemotherapy regimen, no previous Vc or Tax, were randomized to Vc alone (Arm A) or Vc + Tax (Arm B). Arm A pts received Vc 1.5 mg/m2 IV on d 1, 4, 8, and 11 q21d. Arm B pts received dexamethasone premedication, Tax 75 mg/m2 IV on d 1, and Vc 1.3 mg/m2 on d 1, 4, 8, and 11 q21d. Treatment continued until PD, CR, or occurrence of unacceptable adverse event (AE). Objective responses per ...