| Disease | IN THIS PHASE I STUDY, 12 PATIENTS WITH ADVANCED SOLID CANCERS REFRACTORY TO CONVENTIONAL TREATMENT WERE TREATED. COURSES WERE REPEATED EVERY 3 WEEKS. 8 PATIENTS RECEIVED A SINGLE DOSE COURSE OF 40,60,100 OR 150MG/SQ.M.
4 PATIENTS WERE TREATED ON A 5 DAY COURSE AT 5,4 OR 8.5MG/SQ.M./DAY. THERE WERE NO PARTIAL OR COMPLETE REMISSIONS. 1 PATIENT WITH ADENOCARCINOMA OF THE BOWEL HAD STABLE DISEASE AND REDUCTION IN CARCINOEMBRYONIC ANTIGEN LEVELS.
ALL PATIENTS IN THE SINGLE DOSE GROUP AND 1 PATIENT IN THE X5 GROUP HAD MILD TO MODERATE CNS TOXICITY CONSISTING OF LETHARGY, WEAKNESS, DISORIENTATION, SOMNOLENCE, CONFUSION, VIVID DREAMS, AND HALLUCINATIONS.
MILD THROMBOCYTOPENIA WAS OBSERVED IN 1 PATIENT IN THE SINGLE DOSE GROUP ONLY. |