title: 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.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Dept. of Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA 19111, USA. Electronic address: lainie.martin@fccc.edu.
authors.forename: Lainie P
authors.initials: LP
authors.lastname: Martin
authors.affiliation: Gynecologic Oncology Group Statistical & Data Center, Roswell Park Cancer Institute, Buffalo, NY 14263, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Sill
authors.affiliation: Dept. of Clinical Gynecologic Oncology, Hanjani Institute for Gynecologic Oncology, Abington Memorial Hospital, Abington, PA 19001, USA.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Shahin
authors.affiliation: Dept. of OB/GYN, Washington University School of Medicine, St. Louis, MO 63110, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Powell
authors.affiliation: Program in Women's Oncology, Women & Infants Hospital/Alpert School of Medicine, Providence, RI 02905, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: DiSilvestro
authors.affiliation: Dept. of OB/GYN, Oklahoma University Health Science Center, Oklahoma City, OK 73104, USA.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Landrum
authors.affiliation: Dept. of Gynecologic Oncology, Duke University Medical Center, Durham, NC 27710, USA.
authors.forename: Stephanie L
authors.initials: SL
authors.lastname: Gaillard
authors.affiliation: Dept. of Gynecologic Oncology, University of Iowa Hospitals and Clinics, Iowa City, IA 52242, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Goodheart
authors.affiliation: Dept. of Gynecologic Oncology, The Hospital of Central Connecticut, New Britain, CT 06050, USA.
authors.forename: James
authors.initials: J
authors.lastname: Hoffman
authors.affiliation: Dept. of Medical Oncology, Thomas Jefferson University, Philadelphia, PA 19107, USA.
authors.forename: Russell J
authors.initials: RJ
authors.lastname: Schilder
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000077216:Carcinoma, Ovarian Epithelial; D018572:Disease-Free Survival; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010534:Peritoneal Neoplasms / Q000188:drug therapy*; D015996:Survival Rate
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C524459:rilotumumab
keywords: AMG 102; Clinical trial; HGF; OVARIAN CANCER; Rilotumumab MET; Scatter factor