Phase II study of daunorubicin in previously untreated patients with advanced colorectal carcinoma

Fourteen patients with advanced measurable colorectal cancer were treated with daunorubicin hydrochloride (DNR). The drug was administered at a dose of 15 mg/m2 on day 1 through 3 and 8 through 10. After a 4-day rest period DNR was given in weekly injections of 15 mg/m2. There were no partial or complete responses. This study failed to confirm the previously reported therapeutic activity of this agent in colorectal carcinoma, using an identical dose and schedule. We have initiated a phase 1 study of daunorubicin to identify a maximum tolerated dose using an every 3-week schedule for future phase II trials in solid tumors.