A phase II study of sorafenib in advanced uterine carcinoma/carcinosarcoma: A trial of the Chicago, PMH, and California Phase II Consortia

Halla S. Nimeiri, Amit M. Oza, Robert J. Morgan, Dezheng Huo, Laurie Elit, James A. Knost, James L. Wade, Edem Agamah, Everett E. Vokes, Gini F. Fleming*

*Corresponding author for this work

Research output: Contribution to journalArticle

70 Scopus citations

Abstract

Objectives: To determine the efficacy and safety of single agent sorafenib, an oral multi-targeted tyrosine kinase inhibitor, in patients with advanced uterine carcinoma and carcinosarcoma. Methods: This multi-institutional non-randomized phase II trial enrolled two cohorts: patients with uterine carcinoma (cohort A) and uterine carcinosarcoma (cohort B). Eligibility criteria included measurable disease, 0-1 prior chemotherapy regimens, and ECOG performance status ≤ 2. Sorafenib at a dose of 400 mg was administered orally twice daily. A cycle was defined as 28 days. Objective tumor response was the primary endpoint and was assessed following every two cycles. Results: Fifty-six patients (40 with carcinoma, 16 with carcinosarcoma) were enrolled between March 2005 and August 2007. Two (5%) patients with uterine carcinoma had a partial response (PR) and 17 (42.5%) achieved stable disease (SD). Five had SD lasting at least 4 months. The 6-month progression-free survival rate for patients with carcinoma was 29%, and the median overall survival was 11.4 months. No patients with carcinosarcoma had an objective response. Four (25%) had SD, and one had SD lasting 18 months. The 6-month progression-free survival rate was 13%, and the median overall survival was 5.0 months. Grade 3/4 drug related toxicities included: hypertension (13%), hand-foot syndrome (13%), hypophosphatemia (7%), anemia (5%), rash (5%), diarrhea (5%), thrombosis (5%), fatigue (5%) and bleeding (5%). Conclusion: Sorafenib had minimal activity in patients with uterine carcinoma. Predictive factors for potential benefit are needed.

Original languageEnglish (US)
Pages (from-to)37-40
Number of pages4
JournalGynecologic oncology
Volume117
Issue number1
DOIs
StatePublished - Apr 2010

Keywords

  • Endometrial carcinoma
  • Endometrial carcinosarcoma
  • Phase II
  • Sorafenib

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

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    Nimeiri, H. S., Oza, A. M., Morgan, R. J., Huo, D., Elit, L., Knost, J. A., Wade, J. L., Agamah, E., Vokes, E. E., & Fleming, G. F. (2010). A phase II study of sorafenib in advanced uterine carcinoma/carcinosarcoma: A trial of the Chicago, PMH, and California Phase II Consortia. Gynecologic oncology, 117(1), 37-40. https://doi.org/10.1016/j.ygyno.2010.01.013