Phase II evaluation of aclacinomycin A (ACM-A, NSC208734) in patients with metastatic colorectal cancer.

Thirty-two patients with measurable metastatic colorectal cancer refractory to 5-fluorouracil-containing regimens received aclacinomycin A (ACM-A) on a single-dose I.V. schedule administered over 4 hours every 3 weeks. Good-risk patients received ACM-A at the starting daily dose of 100 mg/m2 while patients who had had therapy with radiation or myelosuppressive drugs such as mitomycin C or a nitrosourea compound received an initial daily dose of 80 mg/m2. There were no complete or partial remissions in this study. Twelve of 30 evaluable patients had disease stabilization. Nausea and vomiting were the dose-limiting toxic effects; myelosuppression was moderate, with neutropenia more severe than thrombocytopenia. Other toxic effects included diarrhea (in 53% of the treatment courses), phlebitis (36%), and mucositis (27%). Alopecia was rare and occurred in 3% of treatment courses, while none of the patients developed clinical manifestation of cardiac toxicity. Aclacinomycin-A administered by the single-dose schedule as used in this study is not effective against colorectal cancer.