Pemetrexed (P) in relapsed small cell lung cancer (SCLC): Preliminary results of a phase II trial

7716 Background: Pts with relapsed SCLC have a poor prognosis and few effective treatment options. P is a novel multitargeted antifolate that is active and well-tolerated as a single agent in lung cancer. We undertook a trial to assess the efficacy and safety of single- agent P in both chemosensitive (S) and chemorefractory (R) relapsed SCLC pts. Methods: Eligible pts had limited or extensive- stage SCLC, PS 0 to 2, and only 1 prior chemo regimen. S pts were defined as having had a prior response with disease progression >2 mos from end of 1st-line chemo. R pts were those who progressed while on 1st-line therapy, or had any response but progression <2 mos from end of 1st-line chemo. The initial P dose tested was 500 mg/m2 q 21 d. Planned sample sizes were 36 S pts in a 2-stage sequential fashion with potential early stopping for lack of efficacy or unacceptable toxicity, and 25 R pts in a single-stage design with no stopping rule. The stopping rule was invoked when <3 of 14 qualified S pts responded. The ...