Phase II evaluation of amonafide in renal cell carcinoma. A Southwest Oncology Group study

Invest New Drugs. 1991 Nov;9(4):361-3. doi: 10.1007/BF00183582.

Abstract

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.

Publication types

  • Clinical Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adenine
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / therapeutic use*
  • Carcinoma, Renal Cell / drug therapy*
  • Drug Evaluation
  • Female
  • Humans
  • Imides*
  • Isoquinolines / therapeutic use*
  • Kidney Neoplasms / drug therapy*
  • Male
  • Middle Aged
  • Naphthalimides
  • Organophosphonates

Substances

  • Antineoplastic Agents
  • Imides
  • Isoquinolines
  • Naphthalimides
  • Organophosphonates
  • amonafide
  • Adenine