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A phase II evaluation of AMG 102 (rilotumumab) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: a Gynecologic Oncology Group study.

Publication ,  Journal Article
Martin, LP; Sill, M; Shahin, MS; Powell, M; DiSilvestro, P; Landrum, LM; Gaillard, SL; Goodheart, MJ; Hoffman, J; Schilder, RJ
Published in: Gynecol Oncol
March 2014

OBJECTIVE: This open-label, multi-institutional phase II trial evaluated activity and safety of rilotumumab (AMG 102), a monoclonal antibody that targets HGF (hepatocyte growth factor), the ligand for the MET receptor, in women with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer. PATIENTS AND METHODS: Women were eligible for treatment with rilotumumab if they had measurable disease, a performance status of 0, 1 or 2, previously received platinum-based therapy with a progression-free interval of <12 months or a second recurrence, and adequate bone marrow and organ function. Patients received rilotumumab 20mg/kg IV every 14 days until evidence of unacceptable toxicity or disease progression. The study utilized co-dual primary endpoints of tumor response and six-month PFS to assess the efficacy of rilotumumab. Secondary endpoints included the frequency and severity of adverse events and the duration of progression-free and overall survival. RESULTS: Thirty-one women enrolled and received rilotumumab. All were eligible for analysis. One patient achieved a complete response (3.2%; 90% CI 0.2-14%), and two women had 6-month PFS (6.5%; 90% CI 1.1-19%). Most adverse events were grade 1 or 2, with no grade 4 adverse events. Grade 3 adverse events were gastrointestinal (4), metabolic (3) anemia (3), a thromboembolic event (1), ventricular tachycardia (1), hypotension during infusion (1) and fatigue (1). The study was stopped after the first stage of accrual. CONCLUSION: Rilotumumab was well-tolerated, but had limited activity. The level of activity does not warrant further evaluation of rilotumumab as a single agent in patients with ovarian cancer.

Duke Scholars

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Published In

Gynecol Oncol

DOI

EISSN

1095-6859

Publication Date

March 2014

Volume

132

Issue

3

Start / End Page

526 / 530

Location

United States

Related Subject Headings

  • Survival Rate
  • Peritoneal Neoplasms
  • Ovarian Neoplasms
  • Oncology & Carcinogenesis
  • Neoplasms, Glandular and Epithelial
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Humans
  • Female
  • Fallopian Tube Neoplasms
 

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Martin, L. P., Sill, M., Shahin, M. S., Powell, M., DiSilvestro, P., Landrum, L. M., … Schilder, R. J. (2014). A phase II evaluation of AMG 102 (rilotumumab) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol, 132(3), 526–530. https://doi.org/10.1016/j.ygyno.2013.12.018
Martin, Lainie P., Michael Sill, Mark S. Shahin, Matthew Powell, Paul DiSilvestro, Lisa M. Landrum, Stephanie L. Gaillard, Michael J. Goodheart, James Hoffman, and Russell J. Schilder. “A phase II evaluation of AMG 102 (rilotumumab) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: a Gynecologic Oncology Group study.Gynecol Oncol 132, no. 3 (March 2014): 526–30. https://doi.org/10.1016/j.ygyno.2013.12.018.
Martin, Lainie P., et al. “A phase II evaluation of AMG 102 (rilotumumab) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: a Gynecologic Oncology Group study.Gynecol Oncol, vol. 132, no. 3, Mar. 2014, pp. 526–30. Pubmed, doi:10.1016/j.ygyno.2013.12.018.
Martin LP, Sill M, Shahin MS, Powell M, DiSilvestro P, Landrum LM, Gaillard SL, Goodheart MJ, Hoffman J, Schilder RJ. A phase II evaluation of AMG 102 (rilotumumab) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2014 Mar;132(3):526–530.
Journal cover image

Published In

Gynecol Oncol

DOI

EISSN

1095-6859

Publication Date

March 2014

Volume

132

Issue

3

Start / End Page

526 / 530

Location

United States

Related Subject Headings

  • Survival Rate
  • Peritoneal Neoplasms
  • Ovarian Neoplasms
  • Oncology & Carcinogenesis
  • Neoplasms, Glandular and Epithelial
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Humans
  • Female
  • Fallopian Tube Neoplasms