CLINICAL-EVALUATION AND SAFETY OF LOXIGLUMIDE (CCK-A RECEPTOR ANTAGONIST) IN NONRESECTABLE PANCREATIC-CANCER PATIENTS

The effects and safety of loxiglumide, a cholecystokinin-A (CCK-A) rec eptor antagonist, on advanced pancreatic cancer were investigated in h umans. A perspective, controlled (2.4 g/day vs. placebo), randomized, double-blind, parallel-group study was performed in 64 patients affect ed by nonresectable histologically diagnosed pancreatic cancer. The pa tients were stratified according to sex and stage (A, T-3/N-0-N-1/M(0) ; B, T-1-T-2-T-3/N-0-N-1/M(1); C, relapse after surgical exeresis). Tu mor size (by computed tomography scan) and mortality rate were evaluat ed as efficacy criteria. Clinical symptoms and physical signs, laborat ory tests, and adverse reactions were checked every 6 weeks as efficac y/tolerability criteria. Ferry-two male and twenty-two female patients were considered. A homogeneous distribution of the patients was demon strated in the two treatment groups. Group C was not statistically eva luated for survival and tumor evolution because of its small number. T hree patients dropped out for causes not related to the therapy. No to xic reactions to the drug were reported. Tumor size monitoring within groups A and B demonstrated a similar increase in both the loxiglumide and the placebo group. Survival in group A was higher than in group B (p = 0.0003). In group B, survival was lower in females (F) than in m ales (M) (F = 61.00 +/- 6.47 days, M = 140.44 +/- 22.15 days; p = 0.01 2), while survival by sex was similar in group A and in global analysi s. Survival by treatment was similar for groups A and B. Survival by s urgery was higher (p = 0.049) for surgical palliation than for nonoper ated patients. The tumor grade affected survival but it did not vary b y therapy. In conclusion, sure efficacy of loxiglumide in advanced pan creatic cancer was not demonstrated by our results. In consideration o f its documented tumor growth inhibiting action, we suggest that loxig lumide be tested for recurrence prevention after resective surgery.