Journal article
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
Gynecologic oncology, Vol.125(3), pp.635-639
06/01/2012
DOI: 10.1016/j.ygyno.2012.03.023
PMCID: PMC4370623
PMID: 22446624
Abstract
Purpose: 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.
Details
- Title: Subtitle
- 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
- Creators
- Kimberly E. ResnickJoseph L. KelleyMarta A. CrispensKoen De Geest - University of IowaHeather A. LankesStephen B. HowellMichael A. GoldWilliam E. BradyPeter G. Rose
- Resource Type
- Journal article
- Publication Details
- Gynecologic oncology, Vol.125(3), pp.635-639
- DOI
- 10.1016/j.ygyno.2012.03.023
- PMID
- 22446624
- PMCID
- PMC4370623
- NLM abbreviation
- Gynecol Oncol
- ISSN
- 0090-8258
- Publisher
- Elsevier BV
- Grant note
- DOI: 10.13039/100000054, name: National Cancer Institute, award: CA 27469, CA 37517; name: Angstrom Pharmaceuticals
- Language
- English
- Date published
- 06/01/2012
- Academic Unit
- Obstetrics and Gynecology
- Record Identifier
- 9983557424802771
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