Ukrain (NSC-631570) in the treatment of pancreas cancer.

The aim of this study was to investigate the effects of Ukrain in the treatment of pancreatic cancer. Most patients with advanced pancreas cancer experience pain and have to limit their daily activities because of tumor-related symptoms. Currently, there is no satisfactory treatment for pancreas cancer. The 12-month survival rate is approximately 18% for patients treated with gemcitabine and only around 2% for those treated with 5-fluorouracil. Between January 1, 1996 and December 31, 1999 42 patients with advanced symptomatic pancreas cancer were randomly assigned to receive either vitamin C (5.4 g every second day, repeated 10 times) and Ukrain (10 mg every second day, repeated 10 times) (21 patients), or vitamin C (5.4 g every second day x 10) and normal saline (10 ml) (control group, 21 patients). The primary measure of efficacy was overall survival. Other evaluation criteria included change in body weight, pain intensity (measured by analgesic consumption) and Kamofsky performance status. The one-year survival was 81% in the Ukrain group compared with 14% in the control group. The 2-year survival was 43% in the Ukrain group compared with 5% in the control group. In a recent study of 126 patients treated with gemcitabine or 5-fluorouracil, none of the patients survived beyond 19 months. The longest survival in the Ukrain group was 54 months after the start of therapy (from March 1996 to date). The last follow-up of other patients was on September 6, 2000. Median survival was 17.17 months for Ukrain-treated patients and 6.97 months for the control group and mean survival was 21.86 and 8.92 months for the Ukrain and control groups, respectively (p = 0.001). Ukrain treatment was well tolerated. We conclude that Ukrain prolongs survival of pancreas cancer patients. To determine whether and to what extent this drug can be used as standard therapy in pancreas cancer, a phase III study should be carried out.

RCT Entities:   Population Interventions Outcomes