NSC-631570 (Ukrain) in the palliative treatment of pancreatic cancer. Results of a phase II trial

F. Gansauge· M. Ramadani· J. Pressmar
B. Muehling · K. Stecker · G. Cammerer
G. Leder · H.G. Beger1

1) University of Ulm, Steinhoevelstrasse 9, 89075 Ulm, Germany

Abstract Background: NSC-631570 (Ukrain) is a semisynthetic com­pound of thiophosphoric acid and the alkaloid chelidonine from the plant Chelidonium majus. It has been used in complementary herbal medicine for more than 20 years for the treat­ment of benign and malignant tu­mors. Patients/methods: Between August 1999 and June 2001, 90 pa­tients with histologically proven un-resectable pancreatic cancer were randomized in a monocentric, con­trolled, randomized study. Patients in arm A received 1000 mg gemcitabine/m2, those in arm B received 20 mg NSC-631570, and those in arm C received 1000 mg gemcitabine/m2 followed by 20 mg NSC-631570 weekly. End point of the study was overall survival. Results: In all three arms therapy was well tolerated and toxicity was moderate. At the first re-evaluation in arm A 32%, in arm B 75%, and in arm C 82% showed no change or partial remission according to WHO criteria (arm A versus arm B: P<0.01, arm A versus arm C: P<0.001). Median survival accord­ing to Kaplan-Meier analysis was in arm A 5.2 months, in arm B 7.9 months, and in arm C 10.4 months (arm A versus arm B: P<0.01, arm A versus arm C: P<0.01). Actuarial survival rates after 6 months were 26%, 65% and 74% in arms A B and C, respectively (arm A versus arm B: P<0.05, arm A versus arm C P<0.01). Conclusion: We could show that in unresectable advanced pancreatic cancer, NSC-631570 alone and in combination with gemcitabine nearly doubled the median survival times in patients suffering from advanced pancreatic cancer.