Phase II trial of sunitinib for the therapy of progressive metastatic castration-refractory prostate cancer after previous docetaxel chemotherapy

Clin Genitourin Cancer. 2008 Sep;6(2):134-7. doi: 10.3816/CGC.2008.n.023.

Abstract

Effective options are lacking for progressive castration-refractory prostate cancer (CRPC) after conventional chemotherapy. Sunitinib is an orally administered multitargeted tyrosine kinase inhibitor that is approved multinationally for renal cell carcinoma and gastrointestinal stromal tumors. A phase II trial was conducted to examine the efficacy and toxicities of sunitinib in metastatic CRPC progressing after 1-2 previous chemotherapy regimens including docetaxel. The primary objective was clinical progression-free survival (PFS) with a 12-week PFS > or = 30% assumed to be of interest. Secondary objectives included prostate-specific antigen (PSA) response, modulation of PSA kinetics, objective response, quality of life, pain, survival, and toxicities. Sunitinib 50 mg daily was administered orally on days 1-28 of each 6-week cycle. Patients were treated to a maximum of 8 cycles or until clinically progressive disease or intolerable toxicity.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Androgen Antagonists / therapeutic use
  • Antineoplastic Agents / therapeutic use*
  • Antineoplastic Agents / toxicity
  • Castration
  • Disease-Free Survival
  • Humans
  • Indoles / therapeutic use*
  • Indoles / toxicity
  • Male
  • Neoplasm Metastasis
  • Prostate-Specific Antigen / analysis
  • Prostatic Neoplasms / drug therapy*
  • Prostatic Neoplasms / metabolism
  • Pyrroles / therapeutic use*
  • Pyrroles / toxicity
  • Quality of Life
  • Sunitinib

Substances

  • Androgen Antagonists
  • Antineoplastic Agents
  • Indoles
  • Pyrroles
  • Prostate-Specific Antigen
  • Sunitinib