A phase I trial of pemetrexed and vinflunine (VFL)

13508 Background: VFL is a novel vinca alkaloid microtubule inhibitor with enhanced antitumor activity. We performed a phase I trial of VFL in combination with pemetrexed, a multi-targeted folate antagonist that has shown at least additive activity in combination with other vincas. Methods: A standard dose escalation scheme was used to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of VFL in combination with pemetrexed in patients with refractory solid tumors. Pemetrexed 500mg/m2 was administered intravenously (IV) over 10 minutes followed by VFL at 280mg/m2 (cohort 1), 300mg/m2 (cohort 2) or 320mg/m2 (cohort 3) IV over 20 minutes on day 1 of a 21-day cycle. Results: 19 patients (pts) (10 men, 9 women) with a median age of 58 years (range 32–77) participated. 3 pts had breast cancer, 9 colorectal cancer, 2 non-small cell lung cancer, 2 pancreatic adenocarcinoma, 2 cholangiocarcinoma and 1 sarcoma. The median number of prior therapies in the metastatic setting was 3 (range 1–6)...