Phase II study of PALA and AMSA in advanced renal cell carcinoma.

Ninety-two evaluable patients with measurable renal cell carcinoma participated in a phase II trial of PALA (1500 mg/m2/day for 5 days every 3 weeks) versus AMSA (120 mg/m2 every 4 weeks). No complete responses occurred; objective partial response rates were 5% for PALA and 3% for AMSA. Treatment did not influence survival, but ambulatory patients survived longer than did nonambulatory patients. Mucocutaneous and acute gastrointestinal toxicity occurred with PALA, while hematologic toxicity predominated in AMSA treatments. At these schedules neither drug has significant single-agent activity in renal cell carcinoma.