Continuous five-day infusion of PALA and 5FU: a pilot phase II trial.

In order to determine whether a simultaneous infusion of N-(phospho-n-acetyl)-L-aspartic acid (PALA) was able to increase the rate of antitumor response to 5-fluorouracil (5-FU), a pilot study was conducted. Of 10 evaluable patients with previously drug-untreated colorectal carcinoma, there were only two partial responses, lasting 2.3 and 1.6 months. No partial responses were observed in three evaluable patients with soft tissue sarcomas. The dose-limiting toxicity was dermatitis. The simultaneous infusion of PALA and 5-FU is not likely to produce a high number of antitumor responses of long duration in patients with colorectal carcinoma.