Phase II trial of 10-Edam in patients with advanced colorectal carcinoma.
10-Edam (10-ethyl-10-deaza-aminopterin), an antifolate derivative, was administered to 14 chemotherapy-naive patients with advanced colorectal carcinoma. The drug was given weekly by intravenous route at an initial dose of 80 mg/m2, with escalation or attenuation according to tolerance. Mucositis was dose limiting and occurred in 11 of 14 patients (78.6%). Removal from the study was required in one patient due to progressive pulmonary fibrosis that was histologically identical to methotrexate-induced lung damage. Toxicity was otherwise mild to moderate and included diarrhea, constipation, abdominal discomfort, anorexia, nausea/vomiting, rash, and fatigue. There were no responses to 10-Edam in this study, 95% confidence interval (0-0.23). Stable disease was achieved in four patients; the remaining 10 patients demonstrated progression within 9 weeks of initiating systemic therapy. 10-Edam employed at this dosage and schedule was not effective as a treatment against advanced colorectal carcinoma.
Kemeny
N
N
Solid Tumor Service, Memorial Sloan-Kettering Cancer Center, New York, NY 10021.
Israel
K
K
O'Hehir
M
M
D015746:Abdominal Pain / Q000139:chemically induced; D000328:Adult; D000368:Aged; D000630:Aminopterin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use / Q000633:toxicity; D002277:Carcinoma / Q000188:drug therapy*; D003110:Colonic Neoplasms / Q000188:drug therapy*; D004341:Drug Evaluation; D005260:Female; D005493:Folic Acid Antagonists / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D012004:Rectal Neoplasms / Q000188:drug therapy*; D012074:Remission Induction
D005493:Folic Acid Antagonists; C040210:edatrexate; D000630:Aminopterin