Phase II evaluation of amonafide in renal cell carcinoma

✍ Scribed by Celestia S. Higano; Phyllis Goodman; John B. Craig; Julie A. Kish; Saul E. Rivkin; Michael Wolf; E. David Crawford

• Publisher: Springer US
• Year: 1991
• Tongue: English
• Weight: 205 KB
• Volume: 9
• Category: Article
• ISSN: 0167-6997
• DOI: 10.1007/bf00183582

✦ Synopsis

Twenty four patients with advanced renal cell carcinoma were treated in a phase II trial with amonafide 300-450 mg/m2/day on days 1-5 every 21 days. There were no responders, 6 patients had stable disease, 14 experienced progressive disease and 4 were assumed to be non-responders as no evaluation was performed. There were no fatal toxicities although 8 patients had grade 3 or 4 granulocytopenia, 1 patient had grade 4 thrombocytopenia. Other toxicities included grade 3 diarrhea in 1 patient, grade 3 myopathy in 1 patient, severe nausea and vomiting in 1 patient and a facial rash, possibly a hypersensitivity reaction, in 1 patient. The median survival is 7.5 months. At this dosage and schedule, there is no evidence that amonafide has meaningful anti-tumor activity in patients with advanced renal cell carcinoma.