Phase II Trials of Tetrahydropyranyl-Adriamycin (Pirarubicin) on Renal and Colon Carcinoma, Melanoma, and Soft Tissue Sarcoma

Eighty patients with measurable metastatic colon or renal cancer, melanoma, or sarcoma entered these Phase II studies. A dose of 25 mg/m 2 /day of Pirarubicin (THP) for 3 consecutive days every 4 weeks for the first patients, and then 20 mg/m 2 /day for 3 days every 3 weeks was given by i.v. push. These patients received 225 cycles for a median cumulative dose of 165 mg/m 2 (range: 55-630). The mean number of cycles given was 2.8 (range: 1-8). Only 3 partial responses and 18 stable disease (22%) were observed. Hematologic toxicity was the main problem; it was responsible for one death and a 19% and 44% incidence of grade 3 and 4 WHO neutropenia, respectively