Phase I-II evaluation of razoxane (ICRF-159) and doxorubicin in gastrointestinal cancer. A Southeastern Cancer Study Group Trial.

A Phase I-II study of razoxane (ICRF-159) and doxorubicin was undertaken in 34 adults with advanced gastrointestinal carcinoma. Three dose schedules were studied; weekly razoxane at 600 mg/m2 orally plus doxorubicin 60 mg/m2 every 3 weeks, razoxane at 300 mg/m2 plus doxorubicin 60 mg/m2, and weekly razoxane 300 mg/m2 plus doxorubicin 35 mg/m2 every 3 weeks. This combination produced moderate to severe granulocytopenia in 24 patients including granulocytopenia less than or equal to 500/mm3 in 15. The granulocytopenia occurred regardless of prior chemotherapy and regardless of dose schedule employed. Two septic deaths were recorded but no responses. Further evaluation of this combination is not recommended.