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A phase II study of a urokinase-derived peptide (A6) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma: a Gynecologic Oncology Group study.

AbstractPURPOSE:
This multi-institutional phase II trial assessed the activity and tolerability of the anti-metastatic A6 peptide that binds CD44 in patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC/FTC/PPC).
PATIENTS AND METHODS:
Women with persistent or recurrent EOC/FTC/PPC were eligible for participation if they had measurable disease defined by RECIST criteria, good performance status, and good overall organ function. Patients must have received one prior platinum-based chemotherapeutic regimen and were allowed to have received one additional cytotoxic regimen for the management of recurrent or persistent disease. Women received a 150 mg twice daily subcutaneous dose of A6 and continued on treatment until disease progression or unacceptable toxicity. Primary measures of clinical efficacy were objective tumor response and progression-free survival (PFS) at 6 months. The association of CD44 in archival tissue specimens with clinical outcome was investigated.
RESULTS:
Thirty-one eligible patients were evaluated. No responses were observed. Two patients (6.5%) were progression free for at least 6 months. The median PFS was 2.0 months, and median overall survival has not yet been reached. One patient died of hemorrhage which was possibly study related. There were no grade 4 toxicities. The most common grade 3 toxicities were constitutional (2/31; 6.5%). Archival specimens were available for 27 patients, and 5 (18.5%) were CD44 positive by immunohistochemistry. CD44 expression was not associated with the 6-month PFS (p=0.342).
CONCLUSION:
A6 was well tolerated but had minimal activity in patients with persistent or recurrent EOC/FTC/PPC.
AuthorsMichael A Gold, William E Brady, Heather A Lankes, Peter G Rose, Joseph L Kelley, Koen De Geest, Marta A Crispens, Kimberly E Resnick, Stephen B Howell
JournalGynecologic oncology (Gynecol Oncol) Vol. 125 Issue 3 Pg. 635-9 (Jun 2012) ISSN: 1095-6859 [Electronic] United States
PMID22446624 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2012 Elsevier Inc. All rights reserved.
Chemical References
  • CD44 protein, human
  • Hyaluronan Receptors
  • Peptide Fragments
  • Urokinase-Type Plasminogen Activator
  • acetyl-lysyl-prolyl-seryl-seryl-prolyl-prolyl-glutamyl-glutamic acid amide
Topics
  • Adult
  • Aged
  • Carcinoma, Ovarian Epithelial
  • Disease-Free Survival
  • Fallopian Tube Neoplasms (drug therapy, metabolism)
  • Female
  • Humans
  • Hyaluronan Receptors (biosynthesis)
  • Middle Aged
  • Neoplasm Recurrence, Local (drug therapy)
  • Neoplasms, Glandular and Epithelial (drug therapy, metabolism)
  • Ovarian Neoplasms (drug therapy, metabolism)
  • Peptide Fragments (adverse effects, therapeutic use)
  • Peritoneal Neoplasms (drug therapy, metabolism)
  • Urokinase-Type Plasminogen Activator (adverse effects, therapeutic use)

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