Pilot study of carboplatin/radiotherapy plus ‘dose-dense’ pemetrexed for locally advanced non-small cell lung carcinoma

7571 Background: This is a prospective Pilot/Phase I dose-seeking clinical trial of dose-dense (q2-week) pemetrexed given concurrently with radiotherapy (XRT) and carboplatin for locally advanced non-small cell lung carcinoma (NSCLC). Methods: Eligible patients had Stage III or IV (oligometastatic) NSCLC. Patients received XRT to 63 Gy (conventional fractionation) with carboplatin (AUC = 6) during Weeks 1 and 5 of XRT, and pemetrexed during Weeks 1, 3, 5, and 7 of XRT. Vitamin prophylaxis (B12/folate) was started prior to treatment. The starting dose level of pemetrexed was 300 mg/m2, with plans to dose escalate after 3–6 patients had at least 30 days of evaluability post-treatment without dose-limiting toxicity (DLT). DLT was defined as any Grade 4 toxicity, selected Grade 3 toxicities (chemo-XRT pneumonopathy, esophagitis lasting > 14 days), and/or inability to complete at least 54 Gy of XRT). Consolidation carboplatin (AUC=6) and pemetrexed (500 mg/m2) q3 weeks × 2 cycles was also planned. Results: Fou...