Phase II trial of pemetrexed disodium and gemcitabine in advanced carcinoma of the urothelium (E4802): A trial of the Eastern Cooperative Oncology Group

5079 Background: Advanced urothelial carcinoma is a moderately chemosensitive disease. Although the gemcitabine/cisplatin regimen has essentially replaced M-VAC as front-line therapy, both regimens are moderately toxic and produce similar response rates and median survival. Pemetrexed is a novel multi-targeted antifolate with single agent activity in advanced urothelial cancer. We evaluated pemetrexed in combination with gemcitabine in untreated pts with advanced urothelial cancer. Methods: Patients with TCC or mixed histologies received pemetrexed 500 mg/m2 IV over 10 minutes followed by gemcitabine 1,000 mg/ m2 IV over 30 minutes on day 1, with gemcitabine repeated on day 8 of a 21-day cycle. Dose reductions were mandated for grade 3/4 toxicities. Patients remained on treatment until disease progression or unacceptable toxicity or a maximum of 6 cycles of therapy. Standard RECIST criteria were used to assess response. Results: Total accrual was 46 pts. Two pts never started therapy and were excluded, le...