Phase II trial evaluating combination, weekly gemcitabine and docetaxel in progressive, chemotherapy-exposed NSCLC: Preliminary results of OPN 003.

7295 Background: Docetaxel is the first FDA approved systemic agent for second line therapy (Tx) of NSCLC. In single institution consortium studies, gemcitabine has demonstrated similar activity in the salvage setting. We therefore opted to assess both agents in combination in the salvage Tx of patients (pts) who had received prior systemic chemotherapy.,Eligibility stipulated advanced NSCLC, exposure to one prior platinum based regimen, PS 0-1, and adequate physiologic indices. In radiation-naï ve pts, docetaxel was dosed at 40mg/m days 1 & 8 q 3 wks, and gemcitabine at 800mg/m days 1 and 8 q 3 wks. RT exposed pts received 40mg/m and 600mg/m respectively days 1 and 8. In the absence of grade 3 or 4 neutropenia/thrombocytopenia, the gemcitabine dose was escalated to 1 g/m days 1 and 8.,To date, 25 patients have been enrolled. 17 pts, (8 men, 9 women) enrolled between 6/02 and 1/04, are fully evaluable. The median age is 61 (range, 44 to 79). 12 (71%) are PS 1. All were previously treated with carboplatin, 15 (88%) with paclitaxel, 4 (24%) with docetaxel. 8 (47%) received prior RT, 6 (35%) to brain. Other prior exposures included erolotinib (versus placebo) in 4 pts, CP 547, 632, an experimental oral angiogenesis inhibitor in 2 pts, and bevacizumab in 1. 61 cycles (median 3, range 2-10) have been administered. 6 pts (35%) received ≥ 6 cycles. Grade 3/4 toxicity included neutropenia in 8 (47%) and gemcitabine pneumonitis in 1 (6%). The confirmed response rate is 22%. Median time to progression exceeds 2 mos, and median survival to date exceeds 6 mos.,Combination weekly docetaxel and gemcitabine in the salvage setting post carboplatin-taxane failure is well tolerated, with acceptable toxicity, clear activity and promising median survival. [Table: see text].