A phase II study of 2-methoxyestradiol (2ME2) NanoCrystal ® dispersion (NCD) in patients with taxane-refractory, metastatic castrate-resistant prostate cancer (CRPC)

Michael R. Harrison, Noah Hahn, Roberto Pili, William K. Oh, Hans Hammers, Christopher Sweeney, KyungMann Kim, Scott Perlman, Jamie Arnott, Carolyn Sidor, George Wilding, Glenn Liu

Research output: Contribution to journalArticle

Abstract

Purpose: 2ME2 (Panzem ®) is a non-estrogenic derivative of estradiol with antiproliferative and antiangiogenic activity. Preclinical data support antitumor activity in prostate cancer. This trial evaluated the efficacy of 2ME2 NCD in patients with taxane-refractory, metastatic CRPC. Experimental Design: Patients with metastatic CRPC who had progressed on only one prior taxane-based regimen were eligible. All patients received 2ME2 NCD at 1,500 mg orally four times daily, repeated in 28 day cycles. The primary endpoint was progression-free survival at month 6, with a secondary endpoint of PSA response. An exploratory endpoint was metabolic response on FDG-PET imaging. Results: A total of 50 pts was planned. The study was terminated after 21 pts when a futility analysis showed the primary endpoint was unlikely to be reached. The median number of cycles on study was 2 (range

Original languageEnglish (US)
Pages (from-to)1465-1474
Number of pages10
JournalInvestigational New Drugs
Volume29
Issue number6
DOIs
StatePublished - Dec 2011
Externally publishedYes

Fingerprint

Nanoparticles
Prostatic Neoplasms
Medical Futility
Disease-Free Survival
Estradiol
Research Design
taxane
2-methoxyestradiol

Keywords

  • Antiangiogenesis
  • Antiproliferative
  • Castrate-resistant
  • Clinical trials
  • PET scan
  • Prostate cancer

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Oncology

Cite this

A phase II study of 2-methoxyestradiol (2ME2) NanoCrystal ® dispersion (NCD) in patients with taxane-refractory, metastatic castrate-resistant prostate cancer (CRPC). / Harrison, Michael R.; Hahn, Noah; Pili, Roberto; Oh, William K.; Hammers, Hans; Sweeney, Christopher; Kim, KyungMann; Perlman, Scott; Arnott, Jamie; Sidor, Carolyn; Wilding, George; Liu, Glenn.

In: Investigational New Drugs, Vol. 29, No. 6, 12.2011, p. 1465-1474.

Research output: Contribution to journalArticle

Harrison, Michael R. ; Hahn, Noah ; Pili, Roberto ; Oh, William K. ; Hammers, Hans ; Sweeney, Christopher ; Kim, KyungMann ; Perlman, Scott ; Arnott, Jamie ; Sidor, Carolyn ; Wilding, George ; Liu, Glenn. / A phase II study of 2-methoxyestradiol (2ME2) NanoCrystal ® dispersion (NCD) in patients with taxane-refractory, metastatic castrate-resistant prostate cancer (CRPC). In: Investigational New Drugs. 2011 ; Vol. 29, No. 6. pp. 1465-1474.
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